Friday Report

Friday Report

From Washington, D.C.

  • Roll Call reports,
    • “The Senate fiscal 2025 budget resolution released Friday gives instructions to nine authorizing committees to draft a filibuster-proof reconciliation bill aimed at strengthening border control, buttressing military spending and encouraging domestic energy production.
    • “The fiscal blueprint, written by Senate Budget Chairman Lindsey Graham, R-S.C., gives the authorizing committees until March 7 to fill in the details and provide their respective pieces of the package to the Budget Committee, which will then meld them into one bill.
    • “The plan, to be marked up by the committee Feb. 12 and 13, assumes $342 billion over four years divided between border security, the Pentagon and Coast Guard: $175 billion for the border, $150 billion for defense and $17 billion for the Coast Guard.
    • “The new funding would be fully paid-for, but how they do that specifically is up to the authorizing committees charged with drafting the implementing bill. Committees given instructions to come up with the offsets are given low targets — at least $1 billion — to provide them with maximum flexibility. But the expectation is those committees will exceed those targets.”
  • and
    • “House Republican leaders emerged late Thursday from a roughly three-hour meeting without an agreement on the contours of the massive budget reconciliation package they’ve been talking about for weeks.
    • “But they planned to work through the weekend ironing out details with a goal of marking up the blueprint needed for the filibuster-proof bill early next week.
    • “Speaker Mike Johnson said he’ll be working Saturday and through Sunday’s Super Bowl taking place in New Orleans — in his and Majority Leader Steve Scalise’s home state of Louisiana. President Donald Trump, who hosted House GOP leaders for several hours to discuss reconciliation earlier in the day, is slated to attend the game Sunday.
    • “We are almost there,” Johnson said. “A couple final details that we’ve got to work out.”
  • The Washington Post reports
    • A federal judge said Friday he will temporarily bar the U.S. Agency for International Development from putting 2,200 workers on paid leave as planned by the end of the day after employee groups filed a lawsuit challenging the Trump administration’s authority to shut down the agency.
    • U.S. District Judge Carl J. Nichols said after a hastily called hearing that he will enter a “limited” order in the lawsuit, brought Thursday, and was still weighing whether to order the government to undo the decision to place an additional 500 workers on paid leave.
    • Nichols said he would explain his decision in writing Friday evening, and cautioned that his freeze would be temporary while both sides flesh out their complex but hastily sketched-out claims.
  • OPM on its Fork in the Road webpage acknowledges the federal court order extending the “deadline for the Deferred Resignation Program, the deadline for federal employees to accept the program is being extended to Monday, February 10, at 11:59 pm ET.
  • MedTech Dive tells us,
    • “The American Hospital Association (AHA) has called for the Trump administration to exempt medical devices from tariffs on imports from Canada, China and Mexico.
    • “In a letter sent to President Donald Trump Tuesday, AHA CEO Richard Pollack said disruption to the supply of devices from China would curtail hospitals’ ability to perform life-saving surgeries, protect patients and healthcare workers from contagion, and diagnose and monitor patient conditions.
    • “The AHA is particularly concerned about products that are already in short supply despite ongoing efforts to strengthen the domestic supply chain, Pollack said.”
  • The Government Accountability Office released a report on the Postal Service today.
    • “The U.S. Postal Service is consolidating some of its mail processing facilities. Before doing so, USPS must give public notice of the proposed changes and provide information on how the changes will affect costs, employees, and mail service.
    • “But we found that USPS’s process for estimating the costs of these changes doesn’t align with best practices we considered. For example, USPS doesn’t document all the assumptions and methodologies it uses to develop cost estimates. This information would help decision-makers and oversight groups better understand any risks or uncertainty involved in the estimates.
    • ‘Our recommendations address this issue.

From the public health and medical research front,

  • Fierce Pharma points out,
    • “Since 1999, Feb. 7 has marked National Black HIV/AIDS Awareness Day, drawing attention to the disproportionate impact of HIV on Black communities.
    • “For ViiV Healthcare—the HIV-focused joint venture between GSK, Pfizer and Shionogi—the day represents a dual opportunity to both celebrate progress and plan next steps, according to Randevyn Pierre, ViiV’s head of national field engagement in external affairs.
    • “It’s the moment for us to remember those who have contributed so much to this fight to end HIV/AIDS, and it’s an opportunity for us to celebrate how far we’ve come in HIV treatment, advocacy, activism, research and community work, and also to use that as evidence of how far we can go to end HIV,” Pierre said in an interview with Fierce Pharma Marketing.”
  • The Centers for Disease Control and Prevention announced
    • “Seasonal influenza activity remains elevated and continues to increase across the country. COVID-19 activity is elevated in many areas of the country. RSV activity is declining in most areas of the country.
    • “COVID-19
      • “COVID-19 activity is elevated in many areas of the country. Though wastewater levels are high, emergency department visits are at low levels, and laboratory percent positivity is declining. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • ‘RSV
      • “RSV activity remains elevated but is declining in most areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • “Vaccination
      • ‘Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • The University of Minnesota’s CIDRAP informs us,
    • “Infection with the SARS-CoV-2 Omicron variant confers weak, short-term protection against reinfection, compared with the much more robust and durable protection provided by earlier variants, which highlights the need for periodic vaccine updates, a Cornell University Qatar–led study suggests.
    • ‘The researchers used a test-negative, case-control study design to compare the efficacy of SARS-CoV-2 Omicron infection against reinfection and poor outcomes in Qataris with that offered by infection with previously dominant strains such as Alpha, Beta, and Delta. COVID-positive people were matched with COVID-negative controls in a 1:2 ratio by sex, age-group, nationality, number of underlying medical conditions, vaccine doses received, week of COVID-19 test, testing method, and reason for testing.
    • “The results were published yesterday in Nature. today.”
  • and
    • “Researchers today in JAMA Network Open say children with previous COVID-19 infection have a 25% to 28% higher risk of developing new gastrointestinal (GI) tract symptoms for up to 2 years than kids who did not report SARS-CoV-2 infections.
    • “Studies in adults have shown that the risk of developing new GI symptoms, including abdominal pain, irritable bowel syndrome (IBS), and gastroesophageal reflux disease (GERD), is increased in the year following COVID-19 infection, but it is unknown if kids are at the same increased risk.” 
  • Beckers Clinical Leadership adds “Flu cases reach highest levels since 2009 pandemic: 6 respiratory virus updates.”
    • “Flu levels have surged to their highest levels since the 2009 swine flu pandemic, with influenza-related emergency department visits remaining very high across the U.S. 
    • “The flu continues to drive the most respiratory illness activity and officials warn that flu-related emergency department visits are expected to remain high in the coming weeks. “
  • The American Hospital Association News lets us know.
    • “A study by the Penn State Department of Nutritional Sciences found that low vitamin D levels in the first trimester of pregnancy are associated with higher rates of preterm birth and decreased fetal length.    
    • “More than 25% of women who are pregnant or lactating have lower than recommended levels of vitamin D,” said Alison Gernand, one of the study’s authors.   
    • “Women with higher levels of vitamin D were found to have experienced small but statistically significant increases in fetal length.”
  • The New York Times reports,
    • “Hospital and emergency room patients diagnosed with cannabis use disorder — defined as an inability to stop using cannabis even when the drug is causing harm — died at almost three times the rate of individuals without the disorder over the next five years, according to a study published on Thursday, the largest on the subject.
    • ‘Patients with cannabis use disorder were 10 times as likely to die by suicide as those in the general population. They were also more likely to die from trauma, drug poisonings and lung cancer. Those numbers suggest that cannabis use disorder is about half as dangerous as opioid addiction and slightly less dangerous than alcohol use disorder, the researchers said.
    • “A second report, published on Tuesday, found that more cases of schizophrenia and psychosis in Canada have been linked to cannabis use disorder since the drug was legalized.
    • “Many people think, ‘Oh, cannabis is not harmful — it’s organic, it’s natural; how great,’” said Dr. Laura Bierut, a psychiatrist at Washington University School of Medicine in St. Louis who is an author of an editorial accompanying the study of death risk. But the marijuana sold today is far more potent, and more harmful, than what baby boomers smoked in the 1960s and 1970s, she said.”
  • Per Healio,
    • “Central obesity measures of waist circumference and waist-to-hip ratio appear to be more accurate and consistent indicators of colorectal cancer incidence compared with BMI, according to a study published in JAMA Network Open.
  • and
    • “A blood-based biomarker test may be a reliable method for predicting or ruling out Alzheimer’s disease-related pathology and subsequently for assisting clinicians in formulating a treatment plan for patients, according to new research.
    • “The clinical integration of blood biomarkers for AD holds promise in enabling the early detection of pathology and timely intervention,” Mark Monane, MD, MBA, senior medical adviser at C2N Diagnostics, which funded the study, and colleagues wrote in Diagnostics. “The use of a blood biomarker test that is scalable and accessible as well as acceptable and equitable may address the unmet need in diagnostic testing.”

From the U.S. healthcare business front,

  • Beckers Hospital Review lets us know,
    • “Oakland, Calif.-based Kaiser Permanente posted an operating income of $569 million (0.5% operating marin) in 2024, up from an operating income of $329 million (0.3% margin) in 2023, according to its Feb. 7 financial report. 
    • “Kaiser’s 2024 results include Risant Health, the Washington, D.C.-based nonprofit it formed to “to expand and accelerate the adoption of value-based care in diverse, multi-payer, multi-provider, community-based health system environments.” Risant closed the acquisition of its first health system, Danville, Pa.-based Geisinger, on March 31. It closed the acquisition of its second, Greensboro, N.C.-based Cone Health, on Dec. 1. 
    • “Kaiser reported operating revenues of $115.8 billion for the fiscal year ended Dec. 31, up from $100.8 billion in 2023. The system posted operating expenses of $115.2 billion, up from $100.5 billion in 2023. 
    • “The system posted a net income of $12.9 billion in 2024. Standard accounting rules required Kaiser and Risant to report the net value of unrestricted assets of the organizations that became part of Risant as one-time net income on its financial statements. A total of $6.8 billion of the $12.9 billion in the system’s net income was related to those acquisitions. The system posted a net income of $4.1 billion in 2023. 
    • “Kaiser reported capital spending of $3.7 billion in 2024, down from $3.8 billion in 2023. Its capital spending priorities in 2024 included preparations to meet California’s seismic safety standards by 2030 and supporting investments in leading-edge technologies and environmentally sustainable facilities. As of Dec. 31, Kaiser and Risant had 55 hospitals, 841 medical offices and 40 retail and employee clinics. “
  • Healthcare Dive reports,
    • “Verily, the life sciences arm of technology giant Alphabet, has reached a deal to sell its insurance subsidiary to Elevance, the payer confirmed to Healthcare Dive on Friday.
    • “The subsidiary, called Granular Insurance Company, provides stop-loss insurance for employers meant to protect them from catastrophically high medical costs.
    • “Terms of the deal were not disclosed.”
  • and
    • “A federal bankruptcy judge agreed to a deal on Thursday that places Prospect Medical’s struggling health system Crozer Health into a 30-day receivership.
    • “Under the terms, Pennsylvania regulators will provide Washington, D.C.-based FTI Consulting $20 million to act as an independent monitor and manager of Crozer while Prospect continues to search for a permanent buyer for the four-hospital health system.
    • “The deal isn’t the one Prospect originally intended to present before the Texas court. However, it will keep the lights on at Crozer for at least another 30 days.”
  • BioPharma Dive notes,
    • “Alumis and Acelyrin are merging, the biotechnology companies said Thursday afternoon, in an all-stock deal that leaves the combined company with a bigger cash balance and three drugs in clinical testing. 
    • “Per deal terms, Acelryin stockholders will receive 0.4274 shares of Alumis stock for each share they own, leaving them with about 45% of the combined company and Alumis equity holders with 55%. The new company, which will keep the Alumis name and be run by its executive team, would have $737 million in cash, enough to keep operating into 2027.  
    • “The merged entity will continue to develop Alumis’ two so-called TYK2 inhibitors, one of which is being developed for plaque psoriasis and lupus while the other is targeting neuroinflammatory conditions like multiple sclerosis. Acelyrin’s top prospect, a thyroid eye disease drug called lonigutamab, is part of the deal, too, but the program will be re-evaluated to “confirm its differentiation in a capital efficient manner,” the companies said.”

Thursday Report

From Washington, DC

Photo by Josh Mills on Unsplash

From Capitol Hill

  • The Wall Steet Journal reports
    • “House Republicans wrapped up a more than four-hour meeting at the White House saying that they had closed gaps in their own internal disagreements over extending expiring tax cuts and cutting spending, and they indicated that they were on track to hold a key committee vote next week.
    • “We had a very productive meeting at the White House,” House Majority Leader Steve Scalise (R., La.) told reporters after lawmakers streamed into the Capitol. “We are narrowing down the areas of differences.”
    • “House Republicans from different factions of the party assembled at the White House, each hoping to get Trump’s support for their proposals and resolve disputes that have slowed the party’s progress on taxes, spending and immigration.”
  • The Senate press gallery tells us Thursday evening, “The Senate is considering the nomination of Russell Vought to be Director of the Office of Management and Budget, post cloture. If all time is used, a confirmation vote would occur at 7:00 p.m. We expect several procedural votes to follow the vote on the Vought nomination.”
  • The Washington Post adds,
    • “The Senate on Thursday confirmed Russell Vought as the next director of the powerful White House budget office, installing a conservative fiscal hawk who has promised to pursue sweeping spending cuts and empower President Donald Trump to conform the budget to his political views.
    • “Republicans marshaled a 53-47 vote in support of Vought, who immediately inherits the exceedingly complicated tasks of staving off a government shutdown and preventing a catastrophic debt default — with a political clash over the two critical fiscal deadlines just weeks away.”

From the White House,

  • The Wall Street Journal lets us know,
    • “The White House is working on an executive order to fire thousands of U.S. Department of Health and Human Services workers, according to people familiar with the matter.
    • “Under the order, the Food and Drug Administration, Centers for Disease Control and Prevention and other health agencies would have to cut a certain percentage of employees. 
    • “The order could come as soon as next week, people familiar with the matter said, after workers have an opportunity to take a buyout. The terms of the order haven’t been finalized, however, and the White House could still decide against going forward with the plans.
    • “The job cuts under consideration would affect the Department of Health and Human Services, which employs more than 80,000 people and includes the National Institutes of Health and the Centers for Medicare and Medicaid Services, in addition to the FDA and CDC.
    • “The agencies are responsible for a range of functions, from approving new drugs to tracing bird-flu outbreaks and researching cancer. A loss of staff could affect the efforts depending on which workers are cut and whether they are concentrated in particular areas.
    • ‘The White House on Thursday denied that there is an executive order related to HHS coming.”

From the judicial front,

  • The Wall Street Journal informs us,
    • “A federal judge paused a Thursday deadline for federal employees to decide whether to accept an offer from the Trump administration to resign their jobs voluntarily as the president and his allies attempt to shrink the government workforce.
    • “U.S. District Judge George O’Toole in Massachusetts scheduled a hearing for Monday on whether to grant a temporary restraining order that would block the program while the litigation challenging the offer proceeds.
    • “Employees had previously been told they had until the end of the day on Thursday to decide whether to accept the offer.”

From the Food and Drug Administration front,

  • Per Cardiovascular Business,
    • “The U.S. Food and Drug Administration (FDA) is warning patients with diabetes about the risk of missing critical safety alerts when using continuous glucose monitors, insulin pumps, automated insulin dosing systems and any other similar medical devices. 
    • “While smartphones have made it easier than ever for patients to track their own insulin levels, the convenient technology is far from infallible. In fact, the FDA has received multiple reports of smartphone-compatible medical devices failing to send expected health alerts. When this happens, the agency warned, it creates a risk of patients experiencing severe hypoglycemia, severe hyperglycemia, diabetes ketoacidosis or even death.
    • “Modern medical devices, such as diabetes devices that connect to a smartphone, can provide users with the convenience and flexibility to configure alerts that are personalized to them,” Courtney Lias, director of the Office of In Vitro Diagnostic Products in the FDA’s Center for Devices and Radiological Health, said in a statement. “However, users should stay aware of alert settings and monitor these devices to ensure they continue to receive critical alerts as expected. Even if configured correctly, certain hardware or software changes can interrupt the expected operation of these critical devices, which can lead to patient harm if undetected.”
  • Per a news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of sonpiretigene isteparvovec (Nanoscope Therapeutics) for the treatment of advanced retinitis pigmentosa.
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.

From the Postal Service front,

  • Federal News Network reports,
    • “The Postal Service ended the first quarter of fiscal 2025 with a net profit — a rare moment in the black that Postmaster General Louis DeJoy says is evidence the agency is on the “right path” to overcome long-term financial challenges.
    • “USPS reported $144 million in net income for the first quarter of fiscal 2025, a dramatic reversal from the $2.1 billion net loss for the same quarter last year. The agency’s first quarter is usually its best all year.
    • “USPS, however, still anticipates ending FY 2025 with a $6.9 billion net loss.
    • “The last time USPS saw a net profit was in fiscal 2022, when it ended the year with a $56 billion net profit, ending a nearly 15-year streak of annual net losses.
    • “That sudden change, however, came from Congress passing the Postal Service Reform Act, which ended a mandate for USPS to pre-fund its retiree health benefits well into the future, and brought the agency back to a pay-as-you-go system. The legislation also forgave $57 billion in deferred payments to the retiree health fund.”

From the public health and medical research front,

  • The American Hospital Association News points out,
    • “The U.S. maternal mortality rate decreased to 18.6 deaths per 100,000 live births in 2023, down from 22.3 in 2022, according to new data from the Centers for Disease Control and Prevention. While the mortality rate decreased overall, the maternal mortality rate for Black women in 2023 was 50.3 deaths per 100,000 live births, significantly higher than rates for white (14.5), Hispanic (12.4) and Asian (10.7) women.” 
  • and
    • “The Centers for Disease Control and Prevention Feb. 6 released an advisory  about an outbreak of Ebola in Uganda caused by the Sudan virus disease. There are currently no suspected, probable or confirmed Ebola cases related to the outbreak that have been reported in the United States or outside of Uganda. The CDC recommends travelers monitor themselves for symptoms of SVD while in Uganda and 21 days after leaving.”
       
  • Healio adds
    • “Pregnant women are more likely to die of violence than any medical cause in the U.S. and are at greater risk for violent death compared with nonpregnant women, underscoring the need for intimate partner violence screening, data show. 
    • “In an analysis of CDC mortality data presented at The Pregnancy Meeting, researchers also found that domestic violence firearm legislation was associated with a reduction in homicide and firearm death in pregnancy.”
  • Modern Healthcare reports,
    • “Kaiser Permanente and Tufts University have launched a joint initiative aimed at improving nutritional and dietary health, the organizations said Thursday. 
    • “The Food is Medicine National Network of Excellence comprises Tufts University’s Food is Medicine Institute in Medford, Massachusetts, and Oakland, California-headquartered Kaiser, along with network members such as Blue Cross and Blue Shield of North Carolina, CVS Health, Devoted Health, Elevance Health, Geisinger Health and Highmark Health. 
    • “Network members will track patient outcomes following nutritional and dietary changes and use the data to instruct care delivery and promote food-is-medicine initiatives, according to a news release.”
  • Per the Health Care Cost Institute,
    • The Health Care Cost Institute (HCCI), in collaboration with West Health, conducted an analysis on the use of telehealth mental health services among people with employer-sponsored insurance (ESI). We found that telehealth played an outsized role in the delivery of mental health services starting in 2020, with over 40% of mental health visits occurring via telehealth from 2020-2022. Females, young adults, and people residing in the northeast and west coast received the highest share of mental health care via telehealth. Therapy was the most commonly received mental health service via telehealth.
  • Per AHA News,
    • The Centers for Disease Control and Prevention Feb. 6 released a report on emergency department use during the Los Angeles County wildfires that began Jan. 7. All-cause ED encounters in Los Angeles County initially decreased 9% after the start of wildfires, while wildfire-associated encounters increased eightfold. Wildfire-associated ED encounters peaked from the period of Jan. 7-12, aligning with worsened air quality deemed unhealthy for sensitive groups. The CDC said the initial decrease in all-cause visits could be due to evacuations; alterations in activity patterns; or residents seeking care in clinics, urgent care centers or EDs in neighboring counties.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “A strange thing happened weeks before the Food and Drug Administration approved the first treatment made with CRISPR gene editing, an all-but cure for certain patients with sickle cell disease. CRISPR Therapeutics, the biotech that co-developed the therapy, laid off about 50 employees. “Everyone was dumbfounded,” said a scientist who was let go.
    • “It was one early sign that, for all the public accolades, the CRISPR revolution wasn’t exactly going according to plan. 
    • The gene editing tool, wrested out of bacteria 13 years ago by a fractious group of biochemists, was supposed to change medicine. Excitement surged through boardrooms, patient communities, and the press. No less an authority than a Nobel Prize committee announced, in 2020, that CRISPR “may make the dream of curing inherited diseases come true.” Billions were spent chasing that vision, along with treatments for cancer and other non-hereditary diseases, such as HIV.
    • “Few still talk that way. They sure don’t spend that way.
    • “Over the last 16 monthslayoffs have hit nearly every major CRISPR public and private biotech. Eight public CRISPR stocks are down roughly 50% over the past year. Most are down over 75% from their 2021 peak, when near 0% interest rates and the enthusiasm around mRNA fueled a gene editing bubble. Buzzy startups have closed or merged out of existence, sometimes thunderously. In August, Tome Biosciences collapsed, just eight months after announcing $213 million in funding from biotech’s most prestigious investors and a plan to write “the final chapter in genomic medicines.” [See STAT’s updated CRISPR Tracker here.]
  • From Beckers Payer Issues, we learn that “KLAS Research, a healthcare IT data and insights company, named its “Best in KLAS” payer tools for 2025.”
  • Healthcare Dive notes,
    • “Molina reported mixed fourth-quarter results on Wednesday, beating Wall Street expectations on revenue but missing on earnings. The payer also laid out earnings guidance for 2025 that was lower than analysts had anticipated.
    • The fourth-quarter earnings miss was due to higher medical spending in Medicaid, with no help from the risk corridors that kept the worst of utilization jumps from hitting Molina’s bottom line earlier in 2024. Meanwhile, the lower earnings forecast for this year is because of implementation costs from recent contract wins in Medicaid and for individuals dually eligible for both the safety-net program and Medicare, according to the insurer.
    • “The results and 2025 outlook are “disappointing at face value,” but accretion from the contract wins could set Molina up well for 2026, J.P. Morgan analyst John Stansel said in a note Wednesday.”
  • Per BioPharma Dive,
    • “Bristol Myers Squibb is expanding its plan to cut costs, announcing alongside quarterly earnings on Thursday that it will slash an additional $2 billion in annual expenses by the end of 2027
    • “The announcement builds on cutbacks Bristol Myers announced last April and that affected about 2,200 employees. Bristol Myers didn’t say how many workers will be impacted by the new initiative, but Chief Financial Officer David Elkins told analysts on a conference call that cuts will drive “operational efficiencies across multiple areas of the business.” 
    • “Bristol Myers is already facing limited generic competition for one of its highest-grossing products, the multiple myeloma drug Revlimid. But it’s also bracing for the loss of billions in yearly revenue when patents expire for its cancer immunotherapy Opdivo and blood thinner Eliquis. The planned cuts announced Thursday will help Bristol Myers become a “leaner, more focused company” along the way, CEO Chris Boerner said.”
  • and
    • “Sales of Cobenfy, a new mind-stabilizing medicine, totaled $10 million in the final months of last year, results that fell in line with analyst expectations.
    • “Bristol Myers Squibb, which acquired Cobenfy through its $14 billion purchase of Karuna Therapeutics, gave a first look at the medicine’s launch in an earnings report released Thursday. Cobenfy comes as a capsule. It received Food and Drug Administration approval on Sept. 26 as a treatment for schizophrenia, then launched onto the U.S. market in late October.
    • “By Bristol Myers’ count, the number of filled Cobenfy prescriptions had climbed to around 1,000 per week by the end of January. Chief Commercial Officer Adam Lenkowsky told investors on an earnings call that the “launch is really off to a strong start” and the company has “made very good progress achieving our access goals.”

Midweek Update

From Washington, DC

Capitol Hill News

  • The Senate Press Gallery tells us, “The Senate invoked cloture [this afternoon] on the nomination of Russell Vought to be Director of the Office of Management & Budget on a party line vote of 53-47.” 
  • Modern Healthcare reports,
    • “A package of healthcare bills including measures that targeted transparency, spread pricing and drug rebates fell off a government funding bill at the last minute after Trump objected to other aspects of the bill.
    • “But the ideas behind them remain popular, and these healthcare, business and labor interests want lawmakers to pick up where they left off by including the PBM policies in the next spending package, which Congress must pass by March 14 to prevent a partial shutdown.”

OPM News

  • The Wall Street Journal reports
    • More than 40,000 federal workers have raised their hands to resign, putting the Trump administration at risk of falling short of its target for slashing the government through voluntary measures. 
    • The Office of Personnel Management last week told workers that they have until Thursday to decide whether to take a buyout. People who do so can continue to be paid through September without working, OPM has saidUnions and a dozen attorneys general say the offer isn’t guaranteed. 
    • On a call Wednesday with agency officials, OPM officials said the number of federal workers who have accepted the resignation offer is more than 40,000, according to a person familiar with the matter. Another person confirmed the figure was above 40,000 as of Wednesday afternoon. The Trump administration is expecting numbers to rapidly increase in the final day before the deadline, a White House official said.
    • When it offered the deal last week, the White House said it expected between 5% and 10% of federal employees to accept, leading to about $100 billion in savings annually, without providing information on how the estimate was reached. Officials haven’t translated the percentage range into a specific target for the number of employees it hopes will resign. There are about two million Americans working for the federal government in civilian jobs, though some positions are exempted from the offer.

From the judicial front,

  • Federal News Network informs us,
    • “Three federal unions are asking a federal court to rule that the Trump administration’s “deferred resignation” program is illegal as currently structured, and to order the Office of Personnel Management to give federal workers at least two more months to decide whether to opt in to the unconventional workforce reduction program.
    • “In a lawsuit filed Tuesday, the American Federation of Government Employees, the American Federation of State, County and Municipal Employees and the National Association of Government Employees claim the offer — sent to most federal workers via last month’s “fork in the road” mass email — violates the Administrative Procedure Act (APA) and other federal laws. As currently designed, the program gives employees until Feb. 6 to decide whether or not to resign.
    • “In issuing the directive across the government barely a week after the new administration was sworn in, OPM did not conduct any analysis of which agencies were likely to experience high levels of resignations, the optimal number of resignations, or where staffing was already woefully insufficient such that soliciting resignations would be incontrovertibly harmful to government operations,” attorneys for the labor unions wrote.”
  • Nextgov/FCW adds,
    • “The Office of Personnel Management asked a federal judge Wednesday to dismiss a lawsuit alleging the agency illegally used a new server to send mass emails to federal employees.  
    • “The initial suit, filed in the Washington, D.C. District Court by two anonymous federal employees, claims OPM — working with Elon Musk and his Department of Government Efficiency — violated the 2002 E-Government Act by bypassing a required privacy impact assessment, or PIA, before standing up the email platform.  
    • “Specifically, the lawsuit targets emails related to the Trump administration’s workforce reduction efforts, including the “Fork in the Road” deferred resignation offer, claiming these were sent via the allegedly unauthorized server.”

From the Food and Drug Administration front,

  • Reuters points out,
    • “The U.S. Food and Drug Administration has approved Supernus Pharmaceuticals’ (SUPN.O), opens new tab drug-device combination to treat movement-related symptoms of Parkinson’s disease, the drugmaker said on Tuesday. * * *
    • “The treatment branded Onapgo will be available in the U.S. in the second quarter.
    • “The approval brings to an end the company’s years-long effort to secure the FDA’s nod. The agency had declined to approve Supernus’ application in 2022 and 2024, with the regulator last year requesting additional information related to product quality and the device.”
  • Per a news release, “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of suzetrigine (Vertex Pharmaceuticals) for the treatment of acute pain.” This is the non-opioid acute pain drug (brand name Journavx that the FDA approved last week.
    • “Rates of development of opioid use disorder (OUD) after short-term administration of opioids for acute pain are uncertain, as are rates of NSAID adverse effects (e.g., acute kidney injury, gastrointestinal bleeding, acute coronary syndrome) when used in the post-operative setting. There are also uncertainties in assessing the efficacy of suzetrigine because of lack of data on use of rescue medication in the Phase III trials, which studied the drug’s use after surgery, as well as the use of imputation for pain scores after rescue medication was used in the clinical trial.
    • “The above uncertainties inform ICER’s ratings that the evidence for suzetrigine for the treatment of acute pain in comparison with no systemic treatment, in comparison with opioid analgesics, and in comparison, with NSAIDs are all promising but inconclusive (P/I), meaning moderate certainty of a small or substantial net health benefit, with a small likelihood of a negative net health benefit. 
    • “The FDA approved suzetrigine for acute pain on January 30, 2025. The manufacturer announced a US price of approximately $232.50 for a one-week course of treatment for acute pain.
    • “When compared to treating with opioids, ICER expects the treatment to be cost-saving from a lifetime perspective because of cost offsets due to fewer patients developing OUD.”
  • The revised report “will be reviewed at a virtual public meeting of the Midwest CEPAC on February 28, 2025. The Midwest CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy. Register here to watch the live webcast of the virtual meeting.”

From the public health and medical research front,

  • The New York Times reports,
    • “Dairy cows in Nevada have been infected with a new form of bird flu that is distinct from the version that has been spreading through herds over the last year, the U.S. Department of Agriculture announced on Wednesday.
    • “The finding indicates that the virus, known as H5N1, has spilled from birds into cows at least twice — leading to these two sets of infections — and that it could continue to do so. It also suggests that the virus may pose a persistent risk to cows and to the people who work closely with them.
    • “Before last year, scientists did not know that cows were susceptible to this type of influenza.
    • “This is not what anyone wanted to see,” said Louise Moncla, an evolutionary biologist who studies avian influenza at the University of Pennsylvania. “We need to now consider the possibility that cows are more broadly susceptible to these viruses than we initially thought.”
    • * * *”So far, at least, the spread of D1.1 to cows “doesn’t change the average person’s life,” Dr. Moncla said. But it poses risks for dairy workers and the dairy industry, experts said. It also suggests the possibility that cows already infected once with B.3.13 could become ill a second time with D1.1, Dr. Richard Webby, an influenza expert at St. Jude Children’s Research Hospital, said.
    • “It’s no longer just one virus,” he said. “This, to me, suggests that it’s going to be a lingering problem.”
  • and
    • “The idea was so tantalizing. Drugs in the GLP-1 class, which includes Wegovy and Ozempic, have proved miraculous in treating weight loss and other diseases. And some researchers hoped that the drugs could also help with some of the most difficult diseases to treat — those of the brain, like Parkinson’s.
    • “But now, at least for Parkinson’s, that hope seems dimmed. A rigorous study that randomly assigned Parkinson’s patients to take exenatide, a relative of Ozempic, showed absolutely no benefit or slowing of the course of the degenerative disease after 96 weeks.
    • “And there were no effect on patient symptoms, no effect on brain scans, no subgroup that showed any benefit. No matter how the researchers sliced the data the results were the same.
    • The study, published Tuesday in The Lancet, is bad news for the half million Americans who have been diagnosed with Parkinson’s disease. Symptoms include tremors, stiffness and difficulty with balance. Patients also may develop dementia. Treatments, including medications and deep brain stimulation, can help with symptoms. But no treatment has been shown to slow the disease’s progress.”
  • Per STAT News,
    • “Nine patients with advanced kidney cancer who received an experimental vaccine tailored to their tumors’ specific mutations mounted an immune response to their disease and remained cancer-free for three years, an early-phase clinical trial has shown. 
    • “The study, published Wednesday in Nature, demonstrates the potential of personalized vaccines to change the course of certain cancer types, but larger, longer trials are needed to confirm this approach. Cancer vaccines developed with different molecular recipes are still in their early stages, before strong conclusions can be made, experts said.”
  • Per Cardiovascular Business,
    • “Adults who regularly floss their teeth may be significantly decreasing their risk of stroke or heart rhythm issues, according to new findings to be presented at the American Stroke Association’s International Stroke Conference 2025.
    • “Researchers focused on data from more than 6,000 study participants with an average age of 62 years old. The group was followed for up to 25 years as part of the Atherosclerosis Risk in Communities study. Over the course of the study, 434 participants had a stroke and 1,291 were diagnosed with atrial fibrillation (AFib).
    • ‘Overall, flossing at least once per week was associated with a 22% lower risk of ischemic stroke, a 44% lower risk of cardioembolic stroke and a 12% lower risk of AFib. Flossing more often appeared to lead to more significant risk reductions.
    • “The difference in AFib risk was unexpected, surprising researchers.”
  • and
    • “Forty-eight percent of all U.S. adults incorrectly believe that they should be taking low-dose aspirin every day to minimize their risk of experiencing a heart attack or stroke, according to a new survey out of the University of Pennsylvania.
    • “Yes, doctors did recommend that adults take daily aspirin to protect against cardiovascular disease (CVD) in the past—but that was quite some time ago. In 2019, the American College of Cardiology American Heart Association released new guidelines saying heathy older adults should not be taking low-dose aspirin due to certain risks, including gastrointestinal bleeding. The U.S. Preventive Services Task Force even published separate recommendations in 2022 saying patients 60 or older should not be taking daily aspirin to prevent CVD, highlighting the lack of any real benefits. 
    • “Now, however, many adults still seem to think daily low-dose aspirin is beneficial, even when they are facing no other health problems. * * *
    • “Habits backed by conventional wisdom and the past advice of healthcare providers are hard to break,” Kathleen Hall Jamieson, director of the Annenberg Public Policy Center and director of this survey, said in a statement. “Knowing whether taking a low-dose aspirin daily is advisable or not for you is vital health information.”
    • “Another key takeaway from the survey was that younger patients appear to know more about the benefits and risks of taking daily low-dose aspirin when healthy. For example, 29% of healthy respondents with no family history of CVD who are between the ages of 18 and 39 understand that the risks of daily aspirin outweigh the benefits for someone in their circumstances. That is only true for 11% of adults in that same situation between the ages of 40 and 59, however, and just 7% of adults ages 60 and older.”
  • BioPharma Dive reports,
    • “Novo Nordisk is planning a new Phase 3 trial of its next-generation obesity drug CagriSema that will test different doses and longer duration of treatment, the company said Wednesday.
    • “The announcement comes six weeks after the Denmark-based company released data from another Phase 3 trial that underperformed executives’ expectations on weight loss. Other studies are ongoing, including one with results due this quarter, and Novo plans in early 2026 to ask for regulatory approval of CagriSema.
    • “Novo, which pioneered the use of GLP-1 medicines like Wegovy for weight loss, is in a tight competition with Eli Lilly. The rivalry sharpened when Lilly’s drug Zepbound showed it helped people lose more weight than Wegovy in a head-to-head trial, a finding that put greater scrutiny on Novo’s pipeline.”

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “Healthcare access and affordability is Americans’ top public health concern, followed by ensuring safe food and water and reducing chronic disease, according to a new survey published by Gallup and Emory University’s Rollins School of Public Health. 
    • “Republicans were more likely than Democrats to list ensuring safe food and water as their top public health priority and less likely to list the Centers for Disease Control and Prevention as one of their top three sources of trusted health information.
    • “However, both Democrats and Republicans support federal action on their top priority public health concerns, with 60% of Republicans and more than 75% of Democrats indicating a preference for federal leadership over state action.”
  • The Wall Street Journal reports,
    • Novo Nordisk shares rose after the drugmaker reported strong sales growth for its blockbuster obesity and diabetes drugs and issued a forecast for full-year 2025 results that topped analysts’ expectations.
    • ‘Novo’s shares were up 3% in European trading, and its American depositary shares were up 3.4% in premarket U.S. trading Wednesday after Novo reported fourth-quarter earnings. Investors who had become concerned about an obesity market slowdown, as well as Novo’s competitive position, breathed a sigh of relief.
    • “The story continues to be about market expansion for obesity,” said David Moore, president of Novo Nordisk’s U.S. unit, on a conference call with analysts.”
  • Fierce Pharma tells us,
    • “Less than a decade since it secured its first FDA approval for a biosimilar, Amgen’s portfolio of the copycat drugs is growing and making strong contributions to the company’s top line.
    • “In 2024, when Amgen generated $33.4 billion in revenue, more than $2.2 billion came from sales of its biosimilars. It was a 16% increase from Amgen’s biosimilar sales in 2023 and the company appears ready to top that figure this year.
    • “Less than three months ago, Amgen became the first company in the U.S. to launch a biosimilar version of Regeneron and Bayer’s eye disease blockbuster Eylea. Then last month, Amgen brought to the market a knockoff of Johnson & Johnson immunology powerhouse Stelara.
    • “In the last nine weeks of last year, Amgen’s Eylea biosimilar, Pavblu, generated $31 million in sales.
    • “The current feedback from retina specialists that we’ve been talking to is very enthusiastic, very positive,” Murdo Gordon, Amgen’s global commercial operations chief, said Tuesday during a quarterly conference call. “They are pleased that Amgen is bringing yet another high-quality biosimilar in a very easy-to-use prefilled syringe.”
  • “Beckers CFO Reports informs us,
    • “Burlington, Mass.-based Tufts Medicine recorded an operating loss of $28.9 million (-4.1% operating margin) in the first quarter of 2025, down from an operating loss of $6.5 million (-0.9% margin) in the same quarter last year, according to its Feb. 3 financial report. 
    • “Tufts Medicine’s management said in the report that last year’s first quarter operating loss was reduced by “two significant one-time items.” The system received $41 million in one-time grants from the state and the federal government, and $24 million in revenue from a 340B settlement. Excluding those two items, the system would have seen an operating loss of $71.5 million in the first quarter of 2024. 
    • “Eliminating these one-time items from each fiscal year would show an improvement of $43 million,” management said in the report. 
    • “Tufts reported total operating revenue of $710.7 million in the three months ended Dec. 31, up from $701.5 million reported in the same period last year.” 
  • Per Healthcare Dive,
    • “Teladoc Health has signed a definitive agreement to acquire virtual preventive care provider Catapult Health for $65 million, the telehealth vendor said Wednesday.
    • “The deal, which is expected to close in the first quarter, will help Teladoc catch members’ health conditions early and funnel patients toward the telehealth vendor’s other offerings, including therapists and primary care providers, according to a press release.
    • “Catapult clinicians will also be able to directly enroll eligible members in Teladoc’s chronic condition management programs for diabetes, hypertension, pre-diabetes and weight management — a key area of investment for the telehealth vendor, executives said last month at the J.P. Morgan Healthcare Conference.”
  • and
    • Molina has closed its $350 million acquisition of ConnectiCare, the health insurer announced Tuesday.
    • “The deal adds $1.4 billion in annual premiums to Molina’s topline and 140,000 additional Medicare, Affordable Care Act marketplace and commercial members to the insurer’s rolls.
    • “The acquisition, which was announced last summer, also brings Molina into the state of Connecticut for the first time. ConnectiCare was previously a subsidiary of New York-based nonprofit health plan EmblemHealth.”
  • and
    • “Kroger pharmacies are once again back in Express Scripts’ network, two years after the grocer kicked the massive pharmacy benefit manager to the curb over its allegedly unsustainable pricing model.
    • “Kroger Health, the grocer’s healthcare subsidiary, said on Wednesday it had reached a new agreement with the Cigna-owned PBM that allows customers in Express Scripts’ Medicare prescription drug and Tricare plans for military members to fill prescriptions at Kroger pharmacies.
    • “The new agreement also allows Express Scripts’ commercial and Medicaid clients to add Kroger pharmacies to their networks, according to the announcement. Express Scripts customers can also receive healthcare at Kroger clinics, which offer low-acuity services like vaccinations and preventive care.”

Monday Report

Photo by Sven Read on Unsplash

From Washington, DC,

  • This afternoon, a cloture petition on the nomination of Russell Vought to be Director of the Office of Management and Budget was filed with the Senate. The next step will be a vote on the cloture motion which requires 51 votes.
  • Per a Senate news release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) and Finance Committee member Michael Bennet (D-Colorado), with Ranking Member Ron Wyden (D-Oregon) and Finance Committee member Tim Scott (R-South Carolina), reintroduced the Medicare Multi-Cancer Early Detection (MCED) Screening Coverage Act that would ensure Medicare beneficiaries’ access to cutting-edge tests capable of detecting multiple types of cancer before symptoms appear.  Bipartisan companion legislation (H.R. 842) was also introduced in the U.S. House of Representatives.” * * *
    • Bill text can be found here
  • Nature adds,
    • “US Preventive Services Task Force (USPSTF) guidelines recommend single-cancer screening for select cancers (e.g., breast, cervical, colorectal, lung). Advances in genome sequencing and machine learning have facilitated the development of blood-based multi-cancer early detection (MCED) tests intended to complement single-cancer screening. MCED tests can interrogate circulating cell-free DNA to detect a shared cancer signal across multiple tumor types. We report real-world experience with an MCED test that detected cancer signals in three individuals subsequently diagnosed with cancers of the ovary, kidney, and head/neck that lack USPSTF-recommended screening. These cases illustrate the potential of MCED tests to detect early-stage cancers amenable to cure.”
  • The New York Times reports,
    • The U.S. Food and Drug Administration has given the green light to two biotechnology companies for clinical trials that will transplant organs from genetically modified pigs into people with kidney failure. If successful, these studies could lead to the broader use of cross-species transplantation, a dream of medical scientists for centuries.
    • One of the companies, United Therapeutics Corporation, will begin its trial with six patients, but that number could eventually rise to 50. The other, eGenesis, said it would begin with three patients and grow the study from there.
    • “We are entering a transformative era in organ transplantation,” said Mike Curtis, the president and chief executive of eGenesis.
  • The Government Accountability Office released a report on food safety.
    • “Millions of Americans get sick from foodborne illness every year. While many cases are mild, some cases can result in hospitalization, long-lasting complications, or even death.
    • “In this Q&A, we reported that the safety and quality of the U.S. food supply is governed by at least 30 federal laws, collectively administered by 15 federal agencies. Federal agencies have developed some agency-specific and joint goals related to reducing foodborne illness, but most of these goals have not been met.
    • “A national food safety strategy could help ensure agencies are working together in an effective and efficient manner to reduce foodborne illness.”
  • AHIP offers for public download a report on Medicare Advantage Demographics. “The most recent demographic data [released last Friday January 31] show that MA continued to be a vital source of coverage for low-income Medicare enrollees and diverse populations.”

From the public health and medical research front,

  • The New York Times considers whether the “Bird Flu Could Become Airborne? Scientists were slow to recognize that Covid spreads through the air. Some are now trying to get ahead of the bird flu.”
  • BioPharma Dive adds, “Drugmakers prep for bird flu outbreak, despite continued low risk. While the virus hasn’t made a sustained leap into humans, vaccines and treatments are being developed ahead of an outbreak.”
  • The American Medical Association lets us know what doctors wish their patients knew about Alzheimer’s Disease.
  • The Washington Post informs us,
    • “Those who go hungry or worry about getting food while pregnant are at higher risk of complications such as preeclampsia and gestational diabetes, a new analysis suggests.
    • “The paper, published in JAMA Network Open, used data from an online health survey of more than 19,300 pregnant Kaiser Permanente Northern California members between June 2020 and September 2022. Researchers did not find similar risks among those who received food assistance while pregnant.”
  • Per MedPage Today,
    • “Just over half of patients with overweight or obesity discontinued their GLP-1 receptor agonist within 1 year, with rates even higher among the subset without type 2 diabetes, according to a retrospective cohort study.
    • “Among over 125,000 patients, 53.6% discontinued their GLP-1 receptor agonist by 1 year, and these rates were significantly higher for patients without versus with type 2 diabetes (64.8% vs 46.5%), reported Ezekiel J. Emanuel, MD, PhD, of the University of Pennsylvania in Philadelphia, and colleagues.
    • “Regardless of diabetes status, every 1% of body weight loss was tied to a 3% lower risk of discontinuation, they wrote in JAMA Network Open.
    • “Of the 41,792 patients who stopped treatment and had a weight measurement at discontinuation available, 47.3% and 36.3% of those with and without type 2 diabetes, respectively, restarted their GLP-1 agent at 1 year, and 57.3% and 46.4% restarted within 2 years. For every 1% of body weight regained after discontinuing treatment, there was a 2% to 3% increased hazard of restarting treatment.
    • “The high discontinuation rate did not come as much of a surprise, as prior studies have reported GLP-1 receptor agonist discontinuation rates of up to 81%, Emanuel’s group wrote. They added that the links between weight loss and discontinuation and between weight regain and reinitiation “suggest that weight management is an important factor regardless of type 2 diabetes status.”
  • Per BioPharma Dive,
    • “Adding Pfizer’s cancer drug Braftovi to standard treatments helped people with a form of colorectal cancer live longer without their disease worsening than those who got the typical care alone in a Phase 3 trial, the company said Monday.
    • “The result confirms earlier research from the study, called Breakwater, which had shown that trial volunteers receiving Braftovi were significantly more likely to see their tumors shrink or disappear. Those data were used to support an accelerated U.S. clearance for Braftovi in colorectal cancer in December.”

From the U.S. healthcare business front,

  • Healthcare Dive tells us,
    • “Health supply chain costs and pharmaceutical expenses are projected to rise modestly between July 2025 and June 2026, according to new research from healthcare services company Vizient.
    • “Pharmacy spend will rise 3.8%, driven in part by increased demand for specialty medications. AbbVie’s autoimmune disease drug Humira will continue to be the most popular drug by total spend, however popular GLP-1s like Ozempic, Wegovy and Mounjaro are projected to enter the top-10 list of medications by total spend.
    • “Supply chain costs will rise by approximately 2% during the period, following higher prices for raw materials, increased freight and shipping costs and tariffs on medical-surgical products, according to the report.”
  • Fierce Healthcare adds,
    • “Moody’s Ratings is downgrading the insurance industry’s credit outlook to negative as elevated medical costs continue to batter payers.
    • “Moody’s analysts noted in a report that spending in the commercial market alone is set to increase by 8% this year, the fastest rate recorded in 13 years. Spending in the individual market, meanwhile, is set to climb by 7.5%, another increase that’s higher than in recent years.
    • “Factors driving these spending hikes include inflation, prescription drug spending and higher utilization of behavioral health. Based on those trends, Moody’s projects spending in Medicare Advantage (MA) will also increase by between 5% and 7%.
    • “We are changing our outlook on the health insurance sector to negative from stable,” the Moody’s analysts wrote. “Although we expect EBITDA growth to remain in the low single digits, insurers will continue to grapple with medical costs in excess of reimbursement rates for MA and Medicaid, while commercial coverage also faces continued high medical costs.
  • Per Healthcare Dive,
    • “Cigna has released a plan it says will make healthcare more affordable and accessible for its members — including tying executive compensation to customer satisfaction — as health insurers continue to reckon with discontent with their industry since the killing of a major insurance executive late last year.
    • Cigna plans to start linking bonus awards for high-level officers to the company’s net promoter score, a measure of customer loyalty and satisfaction, the Connecticut-based insurer said Monday.
    • “Cigna will also invest in more care advocates, pare back hurdles to receiving care and make it easier for doctors to update patients on the status of prior authorization requests. Cigna also plans to release an annual “customer transparency” report starting next year with information on its business practices, including data on prior authorization requests, appeals and denials.”
  • and
    • Bankrupt Prospect Medical Holdings said Friday it intends to sell Crozer Health, its four-hospital health system based in Pennsylvania, to an unnamed consortium of nonprofit healthcare operators.
    • Attorneys for Prospect said the proposed sale is the “only viable alternative to an immediate, forced shutdown of the Pennsylvania Hospitals” in documents filed in federal bankruptcy court on Friday.
    • Prospect will appear before the bankruptcy court on Thursday to seek approval for the transaction. As of Monday morning, the hospital operator had yet to file critical details about the sale to the court, including a proposed purchase price or the names of the possible buyers. However, a press release says the deal would include all Crozer hospitals, ambulatory surgery centers, clinics and physician offices.

Friday Report

From Washington, DC,

White House News

  • Per a White House fact sheet,
    • “ELIMINATING 10 REGULATIONS FOR EACH NEW REGULATION ISSUED: Today, President Donald J. Trump signed an Executive Order to unleash prosperity through deregulation. 
    • “The Order requires that whenever an agency promulgates a new rule, regulation, or guidance, it must identify at least 10 existing rules, regulations, or guidance documents to be repealed.  
    • “The Director of the Office of Management and Budget will ensure standardized measurement and estimation of regulatory costs.
    • “It requires that for fiscal year 2025, the total incremental cost of all new regulations, including repealed regulations, be significantly less than zero.'”
  • FEHBlog observation – The White House needs to turn its attention to subregulatory guidance.

Capitol Hill news

  • Modern Healthcare reports,
    • “Doctors and some bipartisan allies on Capitol Hill advanced their campaign to boost Medicare physician reimbursements with the release of new legislation Friday.
    • “The Medicare Patient Access and Practice Stabilization Act of 2025 would give doctors a 6.6% rate increase through 2026 and be retroactive to the beginning of this year, when a 2.9% cut took effect.” * * *
    • “The next government funding bill, which must pass by March 14 to prevent a partial shutdown, is an obvious vehicle. Supporters would likely have a greater chance getting Medicare physician reimbursements into that legislation than into a broader bill with many billions in healthcare cuts that Trump and GOP leaders are drafting on a partisan track.”
  • Per a Senate press release,
    • “U.S. Senate Democratic Whip Dick Durbin (D-IL) and U.S. Senator Chuck Grassley (R-IA), a senior member and former chairman of the Senate Finance Committee, today sent a letter to the President and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA) urging them to embrace their bipartisan legislation, the Drug-price Transparency for Consumers (DTC) Act, to empower patients and providers and commit to voluntarily disclosing list prices in DTC advertisements. 
    • “The Senators wrote, “The United States is one of only two developed countries in the world that permits such pharmaceutical commercials. President Trump’s nominee for Health and Human Services Secretary has expressed interest in outright banning this practice. It would be wise for drug companies to adopt commonsense solutions to address the concerns that have been raised about DTC prescription drug advertising. As you are aware, the United States Senate previously voted unanimously to pass our measure to require that pharmaceutical companies disclose their list prices in DTC ads, and it is our hope that this policy will become law this Congress. This bipartisan legislation would ensure that when patients are bombarded with information about the newest wonder drug, the price is not kept secret. President Trump previously has issued regulations to advance this policy.” * * *
    • Full text of the letter is available here.

OPM News

  • OPM issued an addendum (FEHBlog Dropbox link) to its 2026 FEHB / PSHB call letter today which implements two of the President’s executive orders.
  • Federal News Network reports,
    • “Trump administration officials are taking major steps to cut down the size of the workforce and federal programs at the Office of Personnel Management.
    • “During an internal meeting Friday morning, Trump administration officials directed OPM senior career staff to begin making plans to cut the agency’s workforce and programs by 70%. Multiple sources with direct knowledge of the meeting confirmed the details of the meeting to Federal News Network.
    • “Sources who provided information to Federal News Network on the condition of anonymity said the political leadership at the agency also directed OPM leaders to stop work on anything that is not statutorily required.
    • “Trump administration officials told agency office leaders and associate directors at OPM to prepare briefs over the weekend detailing all of their work and programs that are statutorily required. By Monday, all OPM offices are expected to give political leaders organizational staffing charts with plans for an initial 30% reduction for both federal employees and contractors.”

Postal Service news

  • Federal News Network tells us
    • “The Postal Service’s regulator warns the next phase of a 10-year reform plan would slow mail delivery for a “significant portion of the nation,” but wouldn’t save USPS enough money to justify the changes.
    • “The Postal Regulatory Commission, in an advisory opinion on key parts of the USPS “Delivering for America” plan, found upcoming changes meant to cut billions of dollars each year wouldn’t do much to help the agency regain its long-term financial footing — but would lead to “disproportionate” cuts in service across rural communities.
    • “A PRC official told Federal News Network that nearly 40% of single-piece first-class mail — including letters and postcards — would see a service downgrade under these changes — and that the impact would be even greater in rural areas.
    • “The Commission urges the Postal Service to reconsider whether the speculative, meager gains from this proposal outweigh the certain downgrade in service for a significant portion of the nation,” the PRC wrote Friday.”

FDA News

  • MedPage Today informs us,
    • “The FDA approved an oral combination of meloxicam and rizatriptan (Symbravo) to treat adults with acute migraine with or without aura, Axsome Therapeutics announcedopens in a new tab or window.
    • “Meloxicam is a COX-2 preferential non-steroidal anti-inflammatory drug (NSAID) and rizatriptan is a 5-HT 1B/1D agonist (triptan). The newly approved drug uses a proprietary technology called MoSEIC to increase meloxicam’s solubility and speed of absorption after the drug is taken orally while maintaining its extended plasma half-life.
    • “A significant proportion of migraine patients experience inadequate efficacy with currently available acute treatments, leading to even greater suffering, and an increased risk of worsening of migraine pain and attack frequency,” said Richard Lipton, MD, of Albert Einstein College of Medicine in New York City, in a statement. “Results of multiple clinical trials demonstrate that Symbravo can provide rapid and long-lasting freedom from migraine pain, whether treatment is taken early in the attack while the pain is mild, or later in the attack when the pain may be severe.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today
    • “Seasonal influenza activity remains elevated and continues to increase across the country. COVID-19 activity is elevated in many areas of the country. RSV activity is declining in many areas of the country.
    • “COVID-19
      • “COVID-19 activity is elevated in many areas of the country. Though wastewater levels are high, emergency department visits are at low levels, and laboratory percent positivity was similar to last week. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “RSV activity remains elevated but is declining in many areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.
  • News supplementing the CDC report
    • Health Day notes,
      • “People still see COVID-19 as an ongoing public health threat, even though the pandemic officially ended in 2023, according to a new HealthDay/Harris Poll.
      • “Nearly 3 in 4 people (72%) agree COVID is still a serious public health issue, including more than a third (35%) who strongly agree, the poll found.
      • “COVID has settled into the sort of ongoing health threat already posed by the seasonal flu, which had its turn as a pandemic back in 1918, Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said.
      • “You’ll get hundreds of thousands of people hospitalized with influenza every year,” Offit told HealthDay TV. “You’ll get tens of thousands of people who die every year from influenza. I think that’s what COVID is now. I think this virus will be with us for decades, if not longer.”
    • The University of Minnesota’s CIDRAP lets us know
      • “The nation’s flu activity continued a steady rise last week, with 44 states at the high or very high level and that national test positivity just shy of 30%, the Centers for Disease Control and Prevention (CDC) said today in its weekly update.
      • “Outpatient visits for flulike illness have been above the national baseline for 9 weeks in a row. Of samples that tested positive for flu at public health labs, nearly all were influenza A, and subtyped influenza A samples were about evenly split between the H3N2 and 2009 H1N1 strains.
      • “On the CDC’s flu activity map, most of the country is awash in shades of red that reflect high or very high activity. However, some states are shaded purple, the highest level on the activity scale. They include Southeastern states such as Louisiana, South Carolina, and Tennessee, but also several in the Northeast, including Massachusetts, New Jersey, New York, and New Hampshire.
      • “The CDC reported 16 more pediatric flu deaths, which push the season’s total to 47. The deaths occurred between the middle of December and the week ending January 25. All involved influenza A, and, of 13 subtyped samples, 7 were H1N1 and 6 were H3N2. 
      • “For deaths overall, the level remained steady, with flu making up 1.6% of all deaths last week.
      • “Emergency department (ED) visits for flu are at the very high level and are increasing in all age-groups, making up 7% of all ED visits, the CDC said in its weekly respiratory virus snapshot. Meanwhile, hospitalizations for flu remain elevated and are likewise on the rise for all age-groups.”
  • Per STAT News,
    • “Researchers confirmed that antidepressants lead to a significant reduction in generalized anxiety
    • “The long-awaited update, published by the Cochrane Database of Systematic Reviews, considered by some to be the gold-standard of evidence-based health care, considered evidence from 37 unique randomized control trials with 12,226 participants and found that these drugs are effective compared to a placebo.
    • “The drugs’ long-term impacts are muddier, said Prof. Peter Tyrer, an emeritus psychiatry professor at Imperial College London who was not involved in the study. Some patients have difficulties stopping antidepressants because of withdrawal problems. 
    • “The main reason why antidepressants were preferred to benzodiazepines (drugs that are equally effective in treating generalised anxiety) was the dependence risk, we just seem to have shifted the problem of adverse effects from one class of drugs to another,” Tyrer said. 
  • and
    • “To create one of the most advanced immunotherapies in cancer, CAR-T cell therapies, scientists engineer immune T cells to carry a synthetic protein on their surfaces. This protein, called the chimeric antigen receptor or CAR, is what gives these engineered cells such potency against certain cancers and allows them to recognize and destroy malignant cells. In a new study, scientists have found that CAR-T cells are able to donate this synthetic protein to normal T cells, essentially arming other cells in the immune system with advanced technology to kill cancer.
    • “While this finding is fascinating scientists and cancer researchers, it’s not yet clear how sharing CARs between T cells might impact CAR-T therapy efficacy or influence the design of future synthetic receptors, experts told STAT. However, the work does reveal new biology around how T cells share proteins with one another and gives bioengineers some insights into how to manipulate that process.”

From the U.S. healthcare business front,

  • Beckers Payer Issues tells us,
    • “Aetna, Blue Shield of California and Centene’s Health Net have launched a shared, value-based payment model for reimbursing primary care physicians in California.
    • “The project, led by the California Quality Collaborative and the Integrated Healthcare Association, involves 11 providers across the state, covering about 17,000 patients. The single payment model went live on Jan. 1 and aims to address primary care reimbursement challenges, improve health equity, and boost health outcomes. The model focuses on small, independent practices and could eventually expand beyond California, according to a Jan. 30 news release.
    • “Instead of each health plan using its own payment system, the three insurers use a single, shared system that rewards physicians for providing high-quality care, especially among underserved populations. The CQC will help practices implement the new system, improve care coordination, and integrate mental and physical health services. A platform called Cozeva will provide data to help physicians track their performance and close care gaps.
    • “Participating providers are here. A full model guide is available here.
  • Kauffman Hall offers an infographic about the state of rural healthcare.
  • BioPharma Dive considers the following — “After decades of research, Vertex Pharmaceuticals has an approved pain medicine. Can one of the most powerful biotechs contend with a healthcare system that’s long favored opioids?” The FEHBlog hopes so.
  • Per Fierce Pharma,
    • “One of the most important launches for Novartis in recent years is off with a bang.
    • “Following a broad FDA approval for the adjuvant treatment of HR-positive, HER2-negative early breast cancer in September, Novartis’ Kisqali grew U.S. sales by 65% year over year—or nearly 25% sequentially—to $549 million in the fourth quarter of 2024.
    • “A Novartis presentation released on Friday shows that Kisqali’s new patient starts jumped from an average of around 1,500 per month before the approval to about 2,200 in both October and November. Data for December were not yet available.”
  • and
    • “Two years after AbbVie’s loss of market exclusivity for Humira, those “How it Started and How it’s Going” memes are looking better each quarter for the Illinois drugmaker.
    • “On Friday, when AbbVie reported its quarterly earnings, the pharma giant jacked up its 2027 projected sales of Humira follow-ons Skyrizi and Rinvoq to a combined $31 billion. It is a $4 billion increase on the company’s previous guidance for the immunology duo.
    • “Chief commercial officer Jeff Stewart explained that the projection increase has come because of growing “share capture.” Skyrizi now holds 40% of the total prescription share of the biologics psoriasis market, he said.
    • “Of the $4 billion adjustment to the 2027 projection, $2 billion has been added to Skyrizi’s estimate in inflammatory bowel disease (IBD) and $500 million has been added to Rinvoq’s in the same indication.  
    • “Across the board, we’re seeing tremendous performance, particularly in IBD,” Stewart explained.”

Midweek Update

From Washington, DC,

  • Per a CMS press release issued today,
    • “Lowering the cost of prescription drugs for Americans is a top priority of President Trump and his Administration. In accordance with the statutory requirements of the Inflation Reduction Act, the Centers for Medicare and Medicaid Services (CMS) released the list of 15 drugs selected for the second cycle of the Medicare Drug Price Negotiation Program on January 17, 2025. As the second cycle begins under the Trump Administration, CMS is committed to incorporating lessons learned to date from the program and to considering opportunities to bring greater transparency in the Negotiation Program. CMS intends to provide opportunities for stakeholders to provide specific ideas to improve the Negotiation Program, consistent with the goals of achieving greater value for beneficiaries and taxpayers and continuing to foster innovation.”
  • The American Hospital Association (AHA) News tells us,
    • The AHA Jan. 28 voiced support for bipartisan legislation to reauthorize for five years the Dr. Lorna Breen Health Care Provider Protection Act, which provides grants to help health care organizations offer behavioral health services for front-line health care workers. Introduced yesterday by Sens. Tim Kaine, D-Va., Roger Marshall, R-Kan., Jack Reed, D-R.I., and Todd Young, R-Ind., the bill also would reauthorize a national campaign that provides hospital leaders with evidence-based solutions to support worker well-being. 
  • Federal News Network informs us,
    • “A significant majority of federal employees who took a Federal News Network survey say they don’t plan on accepting the Office of Personnel Management’s offer to resign and go on paid administrative leave.
    • “In a survey of 4,619 federal employees, more than three-quarters of respondents said they don’t intend to accept the deal OPM sent to most civil federal workers in a mass email Tuesday afternoon.” * * *
    • “More than 500 respondents — about 11% of those who took the poll — said they intend to accept the deal.
    • “Among those who expect to accept the offer, 54% said they already had plans to retire from federal service soon or leave for a job outside the federal workforce.” * * *
    • “About 70% of respondents said they don’t have enough information from OPM to make their decision either way. Many said OPM hasn’t provided enough details on what accepting the deal would mean for their health and life insurance plans, or whether it would impact their pensions.”
  • ICD10 Monitor relates,
    • “The Centers for Medicare & Medicaid Services (CMS) have issued the display copy of the Final Rule interpreting the 60-day Refund Rule for Medicare Parts A/B (Traditional Medicare) and C/D (Medicare Advantage, or MA, and the Prescription Drug Plans) established by the Patient Protection and Affordable Care Act.
    • “The Final Rule became effective as of Jan. 1, 2025. The 60-day Refund Rule is included as part of the 3,000+-page 2025 Physician Fee Schedule Final Rule. 
    • “The federal Overpayment Statute requires any person who receives or retains Medicare or Medicaid funds to which they are entitled to report and return any overpayment to the appropriate government official or contractor within 60 days after “identification” of the overpayment, per Section 1128J(d) of the Social Security Act, 42 U.S.C. § 1320a-7k(d).
    • “Failure to report and return an “identified” overpayment in a timely manner could create a false claim situation subject to the False Claims Act (FCA). The False Claims Act, among other things, addresses individuals who knowingly conceal or avoid an obligation to pay or refund money to the federal government.”

From the public health and medical research front,

  • STAT News reports,
    • In July 2022, 988 launched as the number anyone across the country could dial in a mental health crisis. It’s one entryway to a sprawling system of mental health care options, but new research shows that since then, critical crisis services have not become more available — a key objective of the nationwide rollout, designed to strengthen an underfunded, patchwork system that left many people alone in times of crisis. 
    • While calls to the national hotline have continued to increase, fewer psychiatric facilities are offering emergency psychiatric walk-in services, mobile crisis response units, and suicide prevention services, according to a study published Wednesday in JAMA Psychiatry.
    • “988 isn’t going to reach its full potential until there’s a full system of crisis services in every single community,” said Hannah Wesolowski, chief advocacy officer at the National Alliance on Mental Illness.”
  • and
    • From plant-based chocolate milk to fizzy reduced-sugar drinks courtesy of Michelle Obama, the beverage market is always introducing new offerings to appeal to kids. But new dietary recommendations from several major health organizations say that children should really stick with drinking water and plain pasteurized milk.
    • The recommendations for children ages 5-18, released Wednesday, come from the Academy of Nutrition and Dietetics, the American Academy of Pediatric Dentistry, the American Academy of Pediatrics, and the American Heart Association. 
    • Their advice is in keeping with broader draft dietary guidelines created by an advisory committee to the U.S. government at the end of last year, which also said water should be the main thing that people of all ages drink. But the report is notable in carving out specific stances on the wide range of beverage options marketed to families, including plant-based milk and drinks containing non-sugar sweeteners. 
  • Per MedPage Today,
    • Fluctuating cholesterol levels were tied to higher dementia risks in a large study of older adults.
    • Relationships were seen for variability in both total cholesterol and LDL-C levels.
    • Links with dementia were independent of baseline values or whether trends were up or down.
  • Per Healio,
    • The addition of high-dose IV vitamin C to standard chemotherapy nearly doubled overall survival for patients with advanced pancreatic cancer, according to results of a randomized phase 2 trial.
    • Vitamin C also delayed the impact of adverse events and improved quality of life.
  • Per Medscape,
    • “Low-dose aspirin reduced colorectal cancer (CRC) recurrence rates by more than half in patients with tumors harboring mutations in the PI3K signaling pathway, according to findings from the phase 3 ALASCCA trial.
    • “These results stress “the importance of upfront genomic testing” in patients with CRC, said Anna Martling, MD, PhD, from Karolinska Institutet, Stockholm, Sweden, who reported the findings at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium 2025 in San Francisco.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “A big-business coalition is using hospital, insurer and employer healthcare cost information to help companies negotiate the price of services and coverage for employees.
    • “The Purchaser Business Group on Health will combine healthcare price transparency data and other information from providers and insurers with claims data from five large employers to analyze the cost and quality of care across 10 markets, the group said in a Wednesday news release.
    • “We are developing a new level of transparency and analysis that does not currently exist for the commercial market,” PBGH Chief Operating Officer Won Andersen said in the news release. “The project represents a pivotal step toward enhancing transparency and accountability in healthcare spending and purchasing.”
  • Beckers Payer Issues lets us know,
    • “Express Scripts, The Cigna Group’s pharmaceutical benefit manager, will implement new policies designed to prevent members from paying the full list price for drugs. 
    • “Most Express Scripts patients spend less than $100 out-of-pocket for their prescriptions each year, but some patients in high-deductible plans may pay the full list price for medications, according to a Jan. 29 news release. 
    • “Evernorth, Cigna’s health services arm, which manages Express Scripts, will shift its standard offerings to protect patients from paying the list price for medications. The company will also implement better predictability in drug pricing for patients, especially those in high deductible plans, according to the release.” 
  • Per Fierce Healthcare,
    • “Amazon One Medical continues to build out its health system partnerships to expand its network of primary care clinics.
    • “Montefiore Health System is now partnering with the company to open up access to primary and specialty care in New York’s Westchester County and surrounding areas.
    • “Amazon, which bought primary care company One Medical in a $3.9 billion deal in 2023, will open its first primary care offices in Westchester County in affiliation with Montefiore next year, the companies announced Wednesday.
    • “The primary care office will offer same and next-day appointment availability, on-site lab services and wraparound virtual care support for members, Amazon said.
    • “This new relationship will enable patients to have increased access to seamless coordinated care through Amazon One Medical’s innovative care model and Montefiore’s high-quality network of specialists, hospitals, and facilities.
    • ‘Montefiore and Amazon One Medical will determine where to open new facilities over the next several years, executives said.”
  • The Wall Street Journal observes,
    • If obesity is a chronic disease, like kidney or heart conditions, demand for GLP-1 drugs shouldn’t ebb and flow with the seasons. But the weight-loss market is far from typical.
    • After analyzing data going back to 2016, one analyst thinks he has identified a seasonal pattern in demand for drugs such as Eli Lilly’s LLY Zepbound and Novo Nordisk’s NOVO.B Wegovy: The drugs have stellar growth in initial sign-ups in the first half of the year followed by slower gains in the second half. 
    • This pattern resembles the cyclical nature of gym memberships rather than the steady trajectory of most pharmaceutical markets, and for good reason: At the start of the year, people often make resolutions to lose weight, exercise or start new diets. It stands to reason that some of these resolutions might also lead to increased demand for weight-loss prescriptions such as GLP-1 drugs.
    • If the logic is even half-right, it could help explain Eli Lilly’s back-to-back misses [in the second half of 2024] that have confounded Wall Street.
  • MedTech Dive offers “four robotic surgery trends to watch in 2025. Intuitive Surgical will face competition this year from Medtronic and smaller companies like CMR Surgical and Moon Surgical coming to the U.S. market with robotic surgery systems.”

Tuesday Report

OPM Headquarters a/k/a the Theodore Roosevelt Building

From Washington, DC

  • The Washington Post reports,
    • “The White House’s Office of Personnel Management sent an email blast Tuesday to civilian government employees offering them an easy way to quit with pay through Sept. 30, the most sweeping effort yet by the new Trump administration to shrink the ranks of the federal workforce.
    • “The email instructed employees to reply to the message saying they want to resign if they would like to take the offer, which would provide the incentive for workers who accept by Feb. 6, said an Office of Personnel Management spokesperson. Not all employees will be eligible, according to the spokesperson, who said some of the exemptions will be up to agency heads. Additional carveouts exist for immigration officers, some people in national security-focused roles, the Postal Service and the armed forces, the spokesperson said.”
  • Here is a link to OPM’s FAQs on its “Fork in the Road” program.
  • Federal News Network adds,
    • “Federal employees have filed a lawsuit against the Trump administration’s Office of Personnel Management, after the agency created and began testing an email system meant to deliver mass communications directly to federal employees’ inboxes.
    • “The lawsuit from two anonymous federal employees in the executive branch alleges OPM violated the 2002 E-Government Act by not releasing details of how the communication system will manage federal employees’ personal information stored in the system.
    • “Kel McClanahan, executive director of the National Security Counselors law firm, filed the pro bono lawsuit on behalf of the plaintiffs, alleging that the email system poses security risks for federal employees’ personal information.”
  • and
    • “President Donald Trump’s pick to oversee much of the federal government’s real estate portfolio is looking to significantly downsize the amount of office space that agencies occupy.
    • “Michael Peters, commissioner of Public Buildings Service within the General Services Administration, said the agency is looking at cutting up to half its total real estate portfolio over the coming years.
    • “I’m just getting ramped up, but I think our initial review says that number could be up to a 50% reduction on our square footage across the portfolio. We’re not going to do that in six months, but we’re going to try to do this as rapidly as we can,” Peters said Tuesday.
    • “Peters said a “disproportionate amount of that space” would come from the Washington, D.C. metro area — and will include GSA moving out of its own 1800 F Street headquarters.”
  • The President issued an executive order today announcing, “the policy of the United States that it will not fund, sponsor, promote, assist, or support the so-called “transition” of a child [including teenagers under age 19] from one sex to another, and it will rigorously enforce all laws that prohibit or limit these destructive and life-altering procedures.”
    • With respect to the FEHB Program
      • “The Director of the Office of Personnel Management, as appropriate and consistent with applicable law, shall:
        • “(a)  include provisions in the Federal Employee Health Benefits (FEHB) and Postal Service Health Benefits (PSHB) programs call letter for the 2026 Plan Year specifying that eligible carriers will exclude coverage for pediatric transgender surgeries or hormone treatments; and
        • “(b)  negotiate to obtain appropriate corresponding reductions in FEHB and PSHB p
          premiums.”
  • STAT News informs us,
    • “The Center for Medicare and Medicaid Innovation is continuing plans to implement a pilot project testing new ways for state Medicaid programs to pay for multimillion-dollar cell and gene therapies.
    • “The pilot was started during the Biden administration, following an executive order from former President Biden that directed the center to come up with new ideas to lower drug prices. President Trump rescinded that executive order on Inauguration Day, which initially left the future of the pilot unclear. 
    • “President Trump’s Executive Order never rescinded the work that was underway by the CMS Innovation Center on drug models,” a Department of Health and Human Services spokesperson said in an email to STAT.
    • “The pilot addresses an existential issue for state Medicaid programs: how to pay for cell and gene therapies that are highly effective, but expensive, on fixed budgets. 
    • “Two drug manufacturers that make treatments for sickle cell disease are participating: Bluebird Bio, which makes Lyfgenia, and Vertex Pharmaceuticals, which makes Casgevy. Lyfgenia’s list price is $3.1 million, and Casgevy’s list price is $2.2 million.” 
  • The Wall Street Journal lets us know,
    • Novo Nordisk said the Food and Drug Administration approved the diabetes-drug Ozempic to be used to help kidney-disease patients.
    • “Ozempic, or semaglutide, can now be used to reduce the risk of worsening kidney disease or kidney failure in adults with type 2 diabetes and chronic kidney disease, the company said Tuesday.
    • “The approval makes Ozempic the most broadly indicated GLP-1 drug on the market, the Bagsvaerd, Denmark, company said. The FDA approved semaglutide for weight loss under the brand name Wegovy in 2021.”
  • BioPharma Dive adds,
    • “The Food and Drug Administration on Monday expanded use of AstraZeneca and Daiichi Sankyo’s Enhertu, allowing the drug to be given earlier and more broadly in people with an aggressive form of breast cancer.
    • Since 2022, Enhertu has been approved in the U.S. to treat advanced breast tumors expressing “low,” but still detectable, levels of the HER2 protein. With its new decision, the agency widened Enhertu’s availability to include treatment of tumors with “ultralow” HER2 expression. HER2 protein levels must be determined by an FDA-approved test, AstraZeneca and Daiichi said in a statement.”

From the public health and medical research front,

  • The Washington Post reports,
    • “A new strain of avian influenza has been identified for the first time in the United States, raising concerns that the virus is transforming in a way that could eventually cause wider outbreaks among humans.
    • “U.S. officials disclosed the discovery of the virulent H5N9 strain at a California duck farm in a report in recent days to the World Organization for Animal Health, which maintains a database of animal disease threats.
    • “That disclosure comes as the United States confronts a growing outbreak of another bird flu strain, H5N1, that is spreading in poultry farms across the nation and has infected dairy cows for the first time. Human cases have been sporadic and confined mostly to dairy workers exposed to sick animals.
    • “The H5N9 strain itself does not pose a grave threat to humans, officials and experts said.”
  • The American Hospital Association News tells us,
    • “Dementia cases in the U.S. are expected to double by 2060, reaching 1 million new cases per year, according to a study released Jan. 13 by NYU Langone Health. The study found that the risk of developing dementia any time after age 55 is 42%, more than double the risk reported in prior studies. The study authors attributed previous underestimates of dementia risk to unreliable documentation in health records and on death certificates, minimal surveillance of early-stage dementia cases and underreporting of cases by race.” 
  • The New York Times relates,
    • “Rates of sudden unexpected infant death in the United States increased by nearly 12 percent from 2020 to 2022, according to new research published on Monday in the journal JAMA Pediatrics.
    • “Though the study offered some good news — overall infant mortality rates dropped by 24 percent from 1999 to 2022 — it also raised questions about why more babies appear to be dying during sleep, and why rates of sleep-related death remain notably higher among Black, Native American and Pacific Islander babies than among white and Asian infants.
    • “Dr. Elizabeth Wolf, an associate professor of pediatrics with Children’s Hospital of Richmond at Virginia Commonwealth University who was among the new study’s authors, called the findings “pretty alarming.”
    • “The death of an infant from SIDS or SUID is unbelievably horrific,” Dr. Wolf continued, using two acronyms that describe sleep-related deaths among infants. “And we as a public health community need to do everything we can to try and reduce the risk factors as much as possible.”
  • Cardiovascular Business relates,
    • “Cannabis use is on the rise throughout the United States, but it is not as harmless as some people may believe. In fact, according to a new in-depth analysis in Nature Reviews Cardiology, regular cannabis use increases a person’s risk of multiple adverse cardiovascular outcomes, including myocardial infarction, arrhythmias and cardiomyopathy.[1]
    • “The study’s authors, a group of researchers with the Stanford Cardiovascular Institute, explored a wide variety of topics, including ongoing policy trends related to cannabis and the science behind why it appears to make such a significant impact on the cardiovascular system. The group also emphasized that it will be important to learn more about the long-term impact of cannabis use as time goes on. 
    • “Cannabis is emerging as a risk factor for adverse cardiovascular health,” wrote first author Mark Chandy, MD, PhD, who is now an assistant professor at Western University in Ontario, Canada, and colleagues. “With changing public perceptions and an overall decline in tobacco use, cannabis is poised to replace tobacco as a legal drug of choice. Previous restrictions are ending with the widespread decriminalization and legalization of cannabis, boosting use of the drug. A public perception that cannabis is harmless and therapeutically beneficial persists, despite mounting evidence from preclinical and clinical studies showing that cannabis use can harm the cardiovascular system and pose other serious health problems, not unlike tobacco.”
  • Per Beckers Hospital Review,
    • “Cedars-Sinai experts are advocating for patients to have access to GLP-1 medications such as semaglutide as a key component to caring for and preventing cardiovascular disease. 
    • “Physicians are now able to improve multiple “downstream” conditions, such as heart disease, by prescribing one medication “upstream,” according to a Jan. 10 news release from Los Angeles-based Cedars Sinai. 
    • “Amanda Velazquez, MD, director of obesity medicine at the health system, said in the release that semaglutide has enabled patients with high blood pressure to reduce their antihypertensive medications.
    • “Martha Gulati, MD, director of preventive cardiology and the Anita Dann Friedman Chair in Women’s Cardiovascular Medicine and Research at Cedars-Sinai, said although semaglutide has been associated with blood pressure and cholesterol level improvements, it does not replace statins. 
    • ‘Dr. Gulati also said the effectiveness of the drug class raises the important question: “Do we want patients to get CVD and only then treat them? Or should we treat them earlier so we can prevent CVD events?”
  • The Wall Street Journal discusses “The Scientific Fight Over Whether Aging Is a Disease.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Drugmakers raised the list prices of more than 800 prescription drugs for blood pressure, cancer and other conditions by a median 4% at the start of this year.
    • “The modest size of the annual increases could help companies avoid criticism of gouging from President Trump while seeking his administration’s support for such priorities as taking aim at the rebates given to middlemen and altering a federal program providing discounts to certain hospitals. Last year’s median price increase was 4.5%.”
  • Fierce Healthcare points out,
    • “The National Community Pharmacists Association (NPCA) is warning the feds that independent pharmacists are likely to face significant financial hardship due to Medicare drug price negotiations.
    • “In comments submitted on the latest Medicare advance notice, the organization says it conducted a survey of 8,000 pharmacy owners and managers about the drug price negotiation program and found that 93.2% have either decided not to stock drugs under negotiation or are considering not stocking these products.
    • “The survey found that 32.8% of independent pharmacists have already made the decision to not stock one or more of the 10 drugs in the first round of negotiations. In addition, 60.4% of those surveyed said they are considering similar steps.
    • “The NCPA said this is because they’re concerned about “financial losses” through the program.
    • “That will be devastating to the program,” said NCPA CEO B. Douglas Hoey in a press release. “Patients who need these prescriptions will be unable to get them, because their pharmacies cannot participate in the program.'”
  • Per Beckers Hospital Review,
    • “In less than a year, Mark Cuban’s Cost Plus Marketplace has expanded its portfolio to more than 6,000 medicines. 
    • ‘Mark Cuban Cost Plus Drug Co. launched the Marketplace in February 2024, which at the time had more than 4,000 medicines in short supply to directly sell to healthcare facilities. 
    • ‘Since then, customers have realized savings between 40% and 60% compared to traditional wholesalers, according to Chief Commercial Officer Alan Bowe. 
    • “The Marketplace now sells to thousands of hospitals, clinics, ambulatory surgery centers, long-term care sites, dialysis centers and retail pharmacies in all 50 states, Mr. Bowe told Becker’s Jan. 23.”
  • Beckers also brings us up to date on current drug shortages.
  • Fierce Healthcare lets us know,
    • CVS Health is rolling out a new customer app that aims to make it simpler and more convenient for users to manage health benefits, pharmacy benefits and prescriptions.
    • Within the application, users can monitor prescriptions for themselves as well as family members across CVS’ pharmacies, Caremark mail orders and CVS Specialty. This includes “full transparency” into the status of a prescription order and the cost, CVS said.
    • In addition, users can schedule key immunizations for their entire family, and access spending and benefits details from both Aetna and Caremark through the app.
  • Beckers explains the new normal in hospital capacity and announces
    • “UNC Health and Duke University Health System, based in Chapel Hill, N.C., and Durham, N.C., respectively, are uniting to build a comprehensive healthcare campus, featuring the state’s first freestanding children’s hospital.
    • “The two institutions filed legal documents Jan. 28 with the state to establish a nonprofit entity, North Carolina Children’s, according to a joint news release. 
    • NC Children’s will feature a 500-bed children’s hospital on a 100-plus-acre campus at a yet-to-be-identified site in the Research Triangle region.
    • “The new campus will also include a children’s behavioral health center, outpatient clinics, research and teaching facilities, hospitality houses (e.g., Ronald McDonald House) and mixed-use infrastructure to accommodate hotels, restaurants and retail stores, according to the release.”

Monday Report

Photo by Sven Read on Unsplash

From Washington, DC,

  • Nextgov/FCW reports,
    • “Billionaire Elon Musk paid a visit to the Office of Personnel Management’s building on Friday, people familiar have confirmed to Nextgov/FCW.” * * *
    • “Amanda Scales, a former employee of Musk’s artificial intelligence company xAI, is OPM’s new chief of staff.” 
  • Fedscoop informs us,
    • “The Trump administration is giving agency leaders two weeks to submit plans for how they intend to comply with the presidential directive to return all eligible employees to full-time, in-person work, the latest salvo in the restructuring of the federal workforce.  
    • “In a memo sent to agency heads Monday, the acting directors of the Office of Personnel Management and the Office of Management and Budget set a Feb. 7 deadline for return-to-work implementation plans, which will be reviewed and approved by OPM and OMB.”
  • The Senate confirmed Scott Bessent to be Secretary of the Treasury today by a 68-29 vote. The Secretary of the Treasury along with the Secretary of Health and Human Services and the Secretary of Labor, are Affordable Care Act regulators.
  • Roll Call adds,
    • “Bessent, 62, will become the nation’s first openly gay Treasury secretary and the highest-ranking LGBTQ government official in the country’s history.” * * *
    • “He brings a wealth of private-sector experience in the economy and markets to his new role, as well as a concern for the needs of working Americans,” Senate Majority Leader John Thune, R-S.D., said on the floor Monday before the vote.
    • “Senate Finance Chairman Michael D. Crapo, R-Idaho, during the confirmation process similarly praised Bessent’s character, demeanor and experience, while defending him from Democratic attacks about the nominee’s handling of his taxes.”
  • Roll Call also tells us,
    • “The Senate keeps processing President Donald Trump’s nominees this week, but much of the congressional attention will be on South Florida, where House Republicans are gathering for their annual issues and strategy conference.
    • “The conference is taking place at Trump National Doral in Miami, the president’s own private golf club, and Trump is expected to address the assembled lawmakers Monday evening.
    • “Punchbowl News reported over the weekend that Vice President JD Vance is expected to join the retreat as a headliner on Tuesday.
    • “Much of the discussion will focus on trying to plot the way forward for a filibuster-proof budget reconciliation package — especially to try to implement Trump’s immigration and tax policy agenda.”
  • The acting HHS Secretary Dorothy Fink announced,
    • “For nearly 50 years, the Hyde Amendment has protected taxpayer funds administered by the Department from paying for elective abortion. Pursuant to the President’s Executive Order of Jan. 24 (Enforcing the Hyde Amendment) and guidance from Office of Management and Budget, the Department will reevaluate all programs, regulations, and guidance to ensure Federal taxpayer dollars are not being used to pay for or promote elective abortion, consistent with the Hyde Amendment. This review will be conducted consistent with guidance issued by the Office of Management and Budget.”
  • Per BioPharma Dive,
    • “The Food and Drug Administration has approved monthly maintenance dosing of Eisai and Biogen’s Alzheimer’s disease drug Leqembi.
    • “After taking Leqembi every two weeks for 18 months, patients can now transition to a monthly dose that the companies say is supported by modeling of data from Phase 2 and Phase 3 testing. Leqembi works by removing toxic aggregates of a protein from the brain.”

From the public health and medical research front,

  • STAT News reports
    • “In 2022, about 40% of deaths in the U.S. were caused by cardiovascular heart disease, including heart disease and stroke, which kill more people in the U.S. than the next two biggest killers — all forms of cancer and accidental deaths — combined. That’s according to an annual update from the American Heart Association on heart disease and stroke statistics, published today in Circulation
    • “Cardiovascular disease is “common, catastrophic, and costly,” an accompanying editorial notes. Despite its dominance, the overall number of deaths is leveling out after the pandemic shot numbers upwards. Yet contributing risk factors like high blood pressure and obesity continue to rise. 
    • Here are some more interesting findings:
      • The percentage of high schoolers who are physically active for over an hour every day decreased from almost 29% to just under 24% between 2011 to 2021.
      • Nearly 47% of all Americans have high blood pressure. In 2022, the prevalence was worst in Mississippi at about 40% and best in Colorado, at just under 25%. 
      • The rate of gestational diabetes in the U.S. increased 38% from 2016 to 2021, to 8.3% of pregnancies.
  • and
    • “Almost a century after people living in certain neighborhoods around Seattle and Tacoma, Washington were systemically denied financial services — a discriminatory, racist practice known as redlining — young cancer patients in those areas are dying at higher rates than those who live in unaffected areas. 
    • “An association between historic redlining and survival of adult-onset cancers has already been shown, but the data on adolescent and young-adult cancers come from a study published today in CANCER. Researchers analyzed data from 2000 to 2019 in those Washington cities on more than 4,300 patients aged 40 or younger, along with homeowners’ loan data and recent census tracts. They found that five years and 10 years after diagnosis, fewer people in previously redlined neighborhoods were still alive than those unaffected. (That’s about 85% vs. 90% five years out and 81% vs. 88% after ten years.)
    • “The disparity in deaths remained even after adjusting for factors like poverty. It emphasizes the importance of contextualizing today’s health disparities, the authors write, as well as the impact discrimination can have generations down the line.”
  • The New York Times suggests “‘A Dangerous Virus’: Bird Flu Enters a New Phase. A pandemic is not inevitable, scientists say. But the outbreak has passed worrisome milestones in recent weeks, including cattle that may have been reinfected.”
  • KAKE News from Wichita, Kansas, reports,
    • “State public health officials are calling an ongoing tuberculosis outbreak in northeast Kansas “unprecedented.” 
    • “The Kansas Department of Health and Environment [KDHE] reports 66 active cases of tuberculosis and 79 infections in the Kansas City Metro area in 2024. As of this month, the number of active cases rose to 67.
    • “In a Senate Committee on Public Health and Welfare meeting on Tuesday, Deputy Secretary of KDHE Ashley Goss said the department is working collaboratively with the Centers for Disease Control and Prevention.
    • “Some of you are aware we have mobilized staff and resources addressing an unprecedented tuberculosis outbreak in one of our counties,” Goss said. “We are working collaboratively with the CDC on that. The CDC remains on the ground with us to support.” * * *
    • “According to the KDHE website, there are currently 60 active cases of TB in Wyandotte County and seven in Johnson County. 
    • “Despite this, the KDHE says the cases are “very low risk” to the general public, including surrounding counties. 
    • “We are trending in the right direction right now, more to come on that,” Goss said in the meeting. “Hopefully we can get it wound down quickly.” 
  • The American Medical Association lets us know what doctors wish their patients knew about contagious norovirus.
  • Per Healio
    • “The vast majority of people in a study with long COVID had experienced multiple SARS-CoV-2 infections over the course of a 4-year period, researchers reported.
    • “While it is possible that the causes of long COVID could be many and variable depending on the patient population studied, with this cohort the evidence is clear that by having COVID numerous times, patients became more at-risk for developing long COVID,” Sean Clouston, PhD, professor in Stony Brook University’s Renaissance School of Medicine, said in a press release.”
  • and
    • “An investigational blood-based test identified nearly 80% of individuals who had colorectal cancer, according to results of a large prospective trial presented at ASCO Gastrointestinal Cancers Symposium. 
    • “The test also had a specificity greater than 90% for advanced colorectal neoplasia (ACN) and negative-predictive value for ACN.
    • “This new blood test may provide a convenient, effective option for colorectal cancer screening in the intended-use population, and perhaps help us boost adherence to screening,” Aasma Shaukat, MD, MPH, director of outcomes research and Robert M. and Mary H. Glickman professor of medicine at NYU Grossman School of Medicine, said during a press briefing.
  • Per BioPharma Dive,
    • “Treatment with an experimental drug from Akero Therapeutics substantially reversed liver damage in a mid-stage study of people with cirrhosis due to metabolic dysfunction-associated steatohepatitis, a common disease that was formerly known as NASH.
    • Announced Monday by Akero, the study results exceeded investor expectations, more than doubling the value of shares in the biotechnology company. They also helped to push up the stock of 89bio, a competitor developing a similar type of drug to Akero’s.
    • “While the Food and Drug Administration last year approved the first treatment for MASH, its use is limited to people whose livers aren’t yet cirrhotic. According to Akero, its drug is the first compound to show a significant reversal of cirrhosis due to MASH in clinical testing.”
  • The Wall Street Journal reports,
    • “Late-stage trial data for Roche’s drug against muscle-wasting Elevidys showed positive results after two years of treatment for male patients aged 4 or older with Duchenne muscular dystrophy.
    • “The data read-out reduced difficulties in standing, walking and running that were statistically significant, which increased between one year and two years after treatment, the company said. The safety profile was in line with the drug’s profile and no new safety signals were identified, it said.
    • “The treatment is on market for people living with Duchenne aged four years old and over regardless of their ambulatory status in the U.S., United Arab Emirates, Qatar, Kuwait, Bahrain and Oman. It is approved for the treatment of ambulatory individuals aged four through seven years in Brazil and Israel.
    • “Duchenne muscular dystrophy is a genetic disorder characterized by the progressive loss of muscle.”
  • STAT News relates,
    • “Right now, patients with obesity and cirrhosis have few treatments for their progressive liver disease, but a new study offers one available option: bariatric surgery. Weight loss operations significantly cut the long-term risk of developing serious liver complications when compared to standard nonsurgical therapy.
    • “The 62 patients with obesity and cirrhosis in the clinical trial who underwent bariatric surgery — either gastric bypass or gastric sleeve procedures — later had a 72% lower risk of developing more serious liver disease compared to the 106 patients who didn’t have surgery. After 15 years, 20.9% in the surgical group but 46.4% in the nonsurgical group developed one of the major complications of liver disease, including liver cancer and death. 
    • “We showed, regardless of the stage of disease, if we help people to lose weight, we can improve their outcomes. That can provide hope for patients and medical providers,” said Ali Aminian, director of the Bariatric and Metabolic Institute at the Cleveland Clinic and co-author of the study published Monday in Nature Medicine.  “We can change the trajectory of the disease.”
  • Per Beckers Hospital Review,
    • “An Alabama woman who received a gene-edited pig kidney transplant at NYU Langone in November is recovering well more than 60 days after the procedure. 
    • “On Nov. 25, a team of clinicians at the New York City-based health system successfully transplanted UKidney, a 10-gene-edited pig kidney into Towana Looney, 53. Ms. Looney was on a transplant waiting list for nearly eight years before physicians determined the probability of a safe human transplant was slim. 
    • “Now, Ms. Looney is the longest-living recipient of the four Americans who have received a gene-edited pig organ, having surpassed the two-month mark. 
    • “If you saw her on the street, you would have no idea that she’s the only person in the world walking around with a pig organ inside them that’s functioning,” Robert Montgomery, MD, PhD, director of NYU Langone’s Transplant Institute, told the Associated Press in a Jan. 25 report at NBC News. 
    • “Unlike previous xenotransplant patients, Ms. Looney was in better overall health at the time of her transplant, leaving experts optimistic about the potential for broader success in the emerging field of xenotransplantation. Earlier cases involved individuals who were critically ill when they underwent the experimental procedures.”

From the U.S. healthcare business front,

  • Beckers Hospital CFO Report tells us,
    • “Cleveland Clinic served the largest number of patients in its history in 2024 with more than 15 million patient encounters worldwide, generating nearly $16 billion in revenue and ending the year with a 1.7% operating margin.  
    • “The year-end findings come from the annual State of the Clinic address made by CEO and President Tom Mihaljevic, M.D., on Jan. 27. 
    • “Years have passed since the COVID-19 pandemic and healthcare has not recovered. Today, about 40% of U.S. hospitals continue to lose money,” Dr. Mihaljevic said. “In the past, we could predict Cleveland Clinic’s financial health based on our productivity and expense management, but even that has changed.”
    • ‘Dr. Mihaljevic noted that despite the handling of more than 15 million patient encounters, the health system’s 1.7% operating margin fell short of its anticipated 2.7%. He attributed this shortfall to new financial pressures, including unexpected increase in charity care totaling $370 million, surging cost of malpractice insurance and rising costs of drugs due to smaller discounts on medications.”
  • Per Healthcare Dive,
    • “HCA Healthcare reported fourth quarter earnings on Friday that narrowly beat analysts’ expectations following back-to-back hurricanes this fall.
    • “The Nashville-based provider posted $18.3 billion in revenue for quarter, up 6% year over year. However, profit dipped compared to the same period last year, falling from $1.6 billion to $1.4 billion.
    • “Still, several analysts noted HCA’s financial guidance for 2025 is slightly more conservative than expected, raising concerns that Trump administration funding cuts to Medicaid and the Affordable Care Act could impact hospitals’ bottom lines.”
  • Modern Healthcare reports,
    • “Shares of Walgreens Boots Alliance tumbled today following a CNBC report that the Deerfield-based pharmacy chain was unlikely to sell itself to a private-equity firm.
    • “CNBC’s David Faber said on air this morning that sources say the possible deal in which Walgreens would sell itself to New York-based Sycamore Partners is “mostly dead.”
  • Fierce Pharma identifies the ten most anticipated drug launches of 2025.
  • McKinsey & Co. point out “Most top pharma companies derive more than 60 percent of their revenue from therapies for diseases that affect women uniquely, differently, or disproportionately, putting them in a prime position to close the sex- and gender-based health gap.”

Midweek Report

Photo by Juliane Liebermann on Unsplash
  • From a Senate news release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) will hold a nomination hearing on WednesdayJanuary 29, at 10:00AM to consider Robert F. Kennedy Jr. to be Secretary of the U.S. Department of Health and Human Services.” 
  • In the meantime, Dorothy Fink is serving as acting HHS Secretary.
  • FedWeek shares “the key portions of the guidance from OPM on the federal hiring freeze issued by the new Trump administration that addresses issues including general and special exceptions, movement and promotions of current employees and a prohibition on using contractors to fill vacated positions.”
  • The President issued an executive order revoking the affirmative action requirements of E.O. 11246 which President Lyndon Johnson signed in 1965. This action relieves federal government contractors and subcontractors with a contract valued at $100,000 or more and 50 employees or more of the burden to develop and implement a detailed affirmative action program. These businesses remain subject to federal and state laws prohibiting discrimination in employment, e.g., Title VII of the 1964 Equal Employment Opportunity Act.
  • The American Hospital Association News reports,
    • “The Department of Health and Human Services Health Resources and Services Administration is accepting applications until April 22 for its four-year Rural Maternity and Obstetrics Management Strategies Program. HRSA will award up to three cooperative agreements for up to $1 million per year for establishing rural obstetric networks to improve maternity care and access in rural communities. The program runs from Sept. 30, 2025, through Sept. 29, 2029.”

From the judicial front,

  • Per Fierce Healthcare,
    • “The feds intend to appeal a judge’s decision that would force them to recalculate UnitedHealthcare’s Medicare Advantage (MA) star ratings.
    • “The Centers for Medicare & Medicaid Services (CMS) submitted a filing Tuesday in Texas district court saying that it would appeal the November ruling to the Fifth Circuit Court of Appeals. Further details were not included in the court filing.
    • “Judge Jeremy Kernodle of Texas’ Eastern District Court ruled on Nov. 22 that the CMS would have to recalculate UnitedHealth’s MA scores. 
    • “At the center of the case is a single foreign language test phone call that was made to one of UnitedHealthcare’s call centers. The CMS categorized the call as “unsuccessful” because it was disconnected before the test caller could fully engage with a customer service agent, according to UnitedHealth’s lawsuit, which was filed in early October.
  • The Groom Law Group discusses pending ERISA litigation.

From the public health and medical research front,

  • USA Today reports,
    • “The beer, spirits and wine industries were already prepared for a continued lull in sales for 2025, then came the U.S. surgeon general’s call for cancer warning labels on alcoholic beverages.
    • “Add that buzz kill to a flight of other challenges facing the booze business: Dry January – and its sober-curious companion in fall, Sober October – along with the thriving year-round embrace of lower-alcohol and non-alcohol options, especially by younger consumers.
    • “Suddenly, moderation is sweeping the nation. Nearly half of Americans (49%) say they plan to drink less in 2025 – up from 41% who said that was their plan in 2024, according to a new survey, released Tuesday, commissioned by advertising and sales measurement technology firm NCSolutions.”
  • STAT News tells us,
    • “Immune checkpoint inhibitors, drugs that can help make the immune system recognize and destroy cancer more aggressively, are one of the most important medicines in cancer treatment today. Merck’s Keytruda has been used against dozens of different cancers in millions of patients, making it the top-selling drug in the world, with over $25 billion in revenue in 2023. Opdivo, from Bristol Myers Squibb, earned $10 billion in 2023.
    • “Now, a new class of drugs may be emerging to challenge the dominance of these first-generation checkpoint inhibitors. Experts said a certain type of bispecific antibody seems to have hit upon a crucial combination of two cancer targets: the proteins VEGF and either PD-1 or PD-L1. “It’s exactly that,” said Özlem Türeci, the CMO and co-founder of BioNTech. “I think that the anti-PD-1 or PD-L1 and VEGF concept can be a very broad, pan-tumor platform: the next-generation checkpoint modulator.”
  • MedPage Today informs us,
    • “Beneficial pediatric obesity treatment response was associated with a reduced risk of obesity-related events in young adults, a nationwide prospective cohort study in Sweden showed.
    • “Compared with poor response, good response to obesity treatment was associated with lower risk of type 2 diabetes (adjusted HR [aHR] 0.42, 95% CI 0.23-0.77), dyslipidemia (aHR 0.31, 95% CI 0.13-0.75), and bariatric surgery (aHR 0.42, 95% CI 0.30-0.58), reported Emilia Hagman, PhD, of the Karolinska Institute in Sweden, and colleagues.”
    • “Obesity remission showed similar reduced risks, as well as reduced risk of hypertension (aHR 0.40, 95% CI 0.24-0.65). Good response in obesity treatment or obesity remission was associated with a reduced risk of mortality (aHR 0.12, 95% CI 0.03-0.46), though treatment response was not associated with reduced risk for depression or anxiety, they noted in JAMA Pediatrics.
    • “The long-term effects of treating obesity in childhood were largely unknown,” Hagman told MedPage Today in an email. “Many people believe that because maintaining weight loss is so challenging, early treatment might not make a real difference in reducing the risk of serious health problems like type 2 diabetes, high blood pressure, or heart disease later in life. Our research helps answer this critical question and shows the importance of addressing obesity early.”
  • HCPLive adds,
    • “Patient factors, including sociodemographic, healthcare, and clinical elements, were linked to the initiation of semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), in a population with obesity without type 2 diabetes (T2D).1
    • “Among more than 97,000 commercially insured adults in a recent cohort study, approximately 2.0% began semaglutide treatment within 6 months of an obesity diagnosis, with sex, insurance plan, and medication use found to be relevant factors for medication initiation.
    • “The association of these factors with semaglutide initiation were quantified using multivariable logistic regression, and use of common medications, insurance plan structure, employer industry type, and sex were all significantly associated with semaglutide initiation,” wrote the investigative team, led by Andrew C. Stokes, PhD, department of global health, school of public health, Boston University.”

From the U.S. healthcare business front,

  • Healthcare Dive relates,
    • “Johnson & Johnson on Wednesday reported modestly higher-than-expected earnings for the fourth quarter, while cautioning that unfavorable currency exchange rates would temper sales growth this year.
    • “Adjusted earnings per share reached $2.04 in the fourth quarter, higher than the Wall Street consensus of $2.01 and Leerink Partners’ estimate of $1.96, Leerink analyst David Risinger wrote in a note to clients. The company’s sales rose 5.3% to $22.5 billion during the quarter, in line with estimates
    • “Full-year 2024 revenue increased to $88.8 billion from $85.2 billion in 2023. For this year, J&J expects revenue to climb to between $89.2 billion and $90 billion, with a mid-point of $89.6 billion, less than the consensus estimate of $91.1 billion. Shares of the company dropped about 3% in early trading Wednesday, even as the overall market rose.”
  • BioPharma Dive adds,
    • “Johnson & Johnson expects changes in Medicare’s prescription drug benefit will negatively impact its sales by about $2 billion this year, a modest headwind for a pharmaceuticals division the company anticipates will otherwise continue growing.
    • “The changes are the result of a redesign under the Inflation Reduction Act to Medicare’s Part D benefit, which covers outpatient drug treatment. The 2022 law capped annual out-of-pocket spending by people enrolled in Part D to $2,000 beginning this year, and required drugmakers provide additional discounts within certain phases of coverage, among other tweaks.
    • “J&J provided its estimate of the redesign’s financial impact Wednesday alongside earnings for the fourth quarter. In doing so, the company follows Pfizer, which late last year forecast the changes would have a $1 billion net negative impact on 2025 revenue.
    • “The Part D redesign brought on by the Inflation Reduction Act is proving consequential to drugmakers’ business even as the law’s provisions allowing Medicare to negotiate certain drug prices get more attention. Three drugs marketed in whole or in part by J&J were picked by the Biden administration for the first round of negotiations that wrapped up last summer.”
  • The American Hospital Association News points out,
    • “Baxter notified customers on Jan. 22 that allocations for two sodium chloride IV solutions have been increased to 100%. According to Baxter, the products will have a one- to two-week lag time while they progress through the full distribution network after implementing changes. AHA members have notified the association of two- to three-week lag times in some cases following previous allocation updates.”
  • Per Fierce Healthcare,
    • “Credit downgrades for nonprofit hospitals again outpaced upgrades across 2024, though the difference between the two narrowed compared to the year before, according to a review of three credit agencies’ rating actions published Wednesday.
    • “Moody’s, S&P and Fitch collectively issued 95 downgrades and 37 upgrades in 2024, as opposed to 116 and 33 in 2023, wrote Kaufman Hall Managing Director Lisa Goldstein.
    • “She and her firm expect the trend to continue into 2025 “given a growing reliance on government payers, labor challenges and a competitive environment.”
    • “Policy and funding changes will also cast uncertainty into the mix in 2025 and may cause credit deterioration in future years,” she wrote on Kaufman Hall’s website.”
  • Healthcare Dive adds, “Providers to target efficiency, supply chain resilience in 2025. Health systems will work to expand their supply chains and ink nontraditional partnerships in 2025, while trimming excessive AI programs and nonclinical staff.”
  • Meanwhile MedTech Dive notes, “AI in medtech is taking off. Here are 4 trends to watch in 2025. New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain around insurance coverage and generative AI.”
  • Per a news release,
    • The Institute for Clinical and Economic Review (ICER) today announced a new analysis it plans to release on an annual basis titled the “Launch Price and Access Report” which will examine launch pricing for FDA-approved treatments. This report will review the affordability and access of the treatments and their value to the overall health system.
    • “There is no better time to provide an independent analysis on trends in launch pricing – both list and net – and patient access,” stated ICER’s Vice President of Research Foluso Agboola, MBBS, MPH. “ICER typically evaluates promising treatments that pose potential affordability challenges for the U.S. health system. Through this work, ICER will continue to work towards a health system where the pricing of innovative treatments are tied to value, while still ensuring affordability and access for patients.”  * * *
    • “The report is expected to be released in the fourth quarter of 2025.”
  • Alan Fein, in his Drug Channels blog, discusses “The Big Three PBMs’ 2025 Formulary Exclusions: Humira, Stelara, Private Labels, and the Shaky Future for Pharmacy Biosimilars.”

Friday Report

OPM Headquarters a/k/a the Theodore Roosevelt Building

From Washington, DC,

  • OPM has posted on its website its January 15, 2025, call letter for 2026 FEHB benefit and rate proposals. Oddly enough, the 2018 call letter is dated January 11, 2017, while the 2022 call letter is dated February 17, 2021.
  • The 2026 letter fails to address carrier concerns / initiatives to lower benefit and administrative costs.
  • Govexec tells us,
    • “The Office of Personnel Management is updating the qualifications and characteristics used to select and assess members of the Senior Executive Service for the first time in more than 15 years. 
    • “OPM’s updates to the SES executive core qualifications, announced Wednesday, will take effect on July 1. 
    • “Acting OPM Director Robert Shriver wrote in a memo to agency heads that technological advances influenced the decision to make changes to the performance criteria.” 
  • The American Hospital Association News informs us,
    • “The Centers for Medicare & Medicaid Services Jan. 17 announced a record 24.2 million consumers selected health coverage through the Health Insurance Marketplace for the 2025 enrollment period that ended Jan. 15. The total more than doubled the number of enrollees from 2021, CMS said. Of this year’s total, 3.9 million consumers signed up for the first time.”
  • and
    • “The Department of Health and Human Services Jan. 17 announced 15 Medicare Part D drugs selected for the latest round of price negotiations. Negotiations will occur this year and any resulting prices will become effective in 2027. The drugs selected accounted for nearly $41 billion in total Part D gross covered prescription drug costs, or about 14%, between November 2023 and October 2024. 
    • “Drugmakers have until Feb. 28 to decide whether they will participate in negotiations. Prices for the first 10 drugs selected during the first round of negotiations were announced in August, with discounts ranging from 38% to 79% off list prices.”
  • BioPharma Dive adds,
    • “Semaglutide, the popular drug sold by Novo Nordisk as Ozempic for diabetes and Wegovy for weight loss, is among a group of widely used medicines selected by the U.S. government for the next round of price negotiations under a 2022 law aimed at curtailing pharmaceutical costs within Medicare.” * * *
    • “Also on the list are Xtandi, Ibrance, Calquence and Pomalyst, blockbuster drugs for cancers of the prostate, breast, blood and bone marrow. Trelegy Ellipta, an inhaler used for asthma and chronic obstructive sleep apnea, is included, as are Otezla, a psoriasis medicine, and Vraylar, an antipsychotic.”
  • Eli Liily’s semaglutide drugs sold as Mounjaro for diabetes and Zepbound for obesity are not on this list.
  • Per a Labor Department news release,
  • The Washington Post relates,
    • “National security officials are creating an independent panel to examine the origins of the coronavirus pandemic, as scientists and intelligence experts continue to wrestle over the highly charged issue of how the pandemic began.
    • “Jake Sullivan, the Biden administration’s national security adviser, on Sunday asked the Office of the Director of National Intelligence to assemble an outside panel of experts who would take a fresh look at the existing findings on the coronavirus and examine the government’s conclusions, according to two administration officials.
    • “Biden officials say the panel’s creation, coming days before the incoming Trump administration takes office, was driven by Sullivan’s desire to understand a virus that killed more than 1 million Americans and upended society.
    • “Sullivan also requested on Dec. 17 that intelligence agencies update their own assessments of the pandemic’s origins, according to one official who spoke on the condition of anonymity to describe national security matters.” * * *
    • “Republicans on Friday greeted the news with skepticism, calling it overdue and insufficient. Rep. Mariannette Miller-Meeks (R-Iowa), who sat on the House panel reviewing the nation’s coronavirus response, said Democrats had missed opportunities to investigate the virus’s origins during the past four years.”

From the judicial front,

  • Biopharma Dive reports,
    • “CMS’s selection [of Ozempic and Wegovy for its price negotiation list] triggered a lawsuit from Novo, citing CMS inclusion of multiple products by way of selecting one active ingredient.
    • “That suit could provide an opportunity, albeit a long shot, to exempt Wegovy and Rybelsus from this round of price negotiations. CMS in its guidance said it applies price negotiations across products using the same active ingredient or moiety because it reduces the incentive for companies to engage in “product hopping,” or making small changes in drug formulation to extend patent-protected exclusivity.
    • “Novo claimed the guidance went beyond what the IRA allowed because it interpreted the law’s call for price negotiations on “drug products” and “biological products” to mean all those with the same active moiety or ingredient. By grouping together all of Novo’s insulin products, CMS invoked negotiations on more than the 10 products permitted by the IRA in the initial round, Novo argued.”
  • The Wall Street Journal points out,
    • “A group representing 100 large employers sued the Labor Department over Biden administration rules aimed at ensuring mental-health treatment is covered like conditions such as cancer and heart disease. 
    • “Filed in federal court Friday, just days before Donald Trump’s inauguration, the suit seeks to block the regulations. It argues the Biden-era rules overstep a 2008 law requiring health plans to cover mental-health and addiction care on par with other medical care. 
    • “The lobbying group behind the suit—the Erisa Industry Committee, or ERIC—hopes that stopping enforcement now will give the new Trump administration room to revise or issue new regulations, said Tom Christina, executive director of the ERIC Legal Center. Unlike an executive order, which can be rescinded with the stroke of a pen, agency-issued regulations must go through a lengthy process to be revoked or revised.
    • “ERIC’s lead lawyer in the case is Eugene Scalia, who served as Secretary of Labor in Donald Trump’s first presidential term and is now an attorney with Gibson Dunn. The approximately 100 companies it represents, which include brands such as PepsiCo, Comcast and L’Oréal USA, are subject to the regulations because they sponsor health-insurance plans for their employees.” * * *
    • “ERIC’s members support the goals of 2008 law and recognize America’s mental-health and substance-abuse crises, Christina said. But the group believes the latest rule crosses the line into mandating mental-health benefits. Connie Garner, a former Senate policy director who helped draft the 2008 law, said new efforts to improve upon it should give priority to boosting the quality of care and the size of the mental-health workforce rather than focusing on analysis and compliance requirements.”
  • Good luck ERIC in your challenge to this ridiculously complicated regulation.
  • The Wall Street Journal adds,
    • “The U.S. Justice Department has filed suit against Walgreens, accusing the company of helping to fuel the opioid crisis by filling millions of unlawful prescriptions.
    • “The pharmacy and retail chain since August 2012 filled prescriptions that lacked a legitimate medical purpose, were invalid or weren’t issued in professional practice, the Justice Department said Friday. These prescriptions included excessive quantities and early refills of opioids, as well as the “trinity,” a drug composed of an opioid, a benzodiazepine and a muscle relaxant, according to the complaint.
    • “We are asking the court to clarify the responsibilities of pharmacies and pharmacists and to protect against the government’s attempt to enforce arbitrary ‘rules’ that do not appear in any law or regulation and never went through any official rule-making process,” a Walgreens spokesperson said.
    • “The company added that it stands behind its pharmacists, all of whom it said are “dedicated healthcare professionals who live in the communities they serve, filling legitimate prescriptions for FDA-approved medications written by DEA-licensed prescribers in accordance with all applicable laws and regulations.”
  • Per Fierce Healthcare,
    • “MultiPlan and its partner health insurers are pushing back against antitrust allegations from numerous provider organizations, filing Thursday a motion to dismiss their collective lawsuit against the data company. 
    • “Individual health systems and the American Medical Association (see below) have filed cases against MultiPlan in recent months, leading to multidistrict litigation consolidating dozens of plaintiff complaints. They accuse the company of forming agreements with insurers—UnitedHealth Group, Elevance Health, Aetna and Cigna are listed as “co-conspirators”—to set out-of-network prices using a common collective data set and methodology, as opposed to competing with each other individually.”
    • “MultiPlan and the insurers, in their Thursday filing, argued that the plaintiffs do not plausibly allege antitrust standing, an antitrust conspiracy or the standalone product that could be fixed. The company’s out-of-network reimbursement-recommendation product uses common, publicly available data sources, not competitor data, when making its recommendations to managed care organizations and third-party administrators. 
    • “Legal representation for MultiPlan and the partner insurers also noted that “numerous” similar lawsuits brought against MultiPlan in the past—including by some of the consolidated complaint—have been dismissed for failing to make an antitrust case.”
  • Good luck, Multiplan and partners.
  • Per Healthcare Dive,
    • “The Federal Trade Commission has reached a deal with Welsh, Carson, Anderson and Stowe limiting the private equity firm’s influence in the U.S. anesthesia market.
    • “The settlement released Friday comes after the FTC threatened Welsh Carson with another lawsuit — this time in the agency’s own administrative court — after regulators failed to triumph in federal proceedings last year over the PE firm’s alleged anticompetitive behavior in Texas.
    • “The deal is relatively toothless, including no monetary penalties or admission of wrongdoing for Welsh Carson. However, Welsh Carson will have to limit its involvement with its anesthesia business that’s been accused of suppressing competition and notify the FTC of any acquisitions or investments in anesthesia and other hospital-based physician practices in the future.”
  • and
    • “The Department of Justice recorded over $2.9 billion in settlements and judgments under the False Claims Act in 2024, with the majority of settlements coming from healthcare.
    • “Healthcare settlements totaled $1.67 billion. The money will go toward restoring defrauded federal healthcare programs, including Medicare, Medicaid and the military health program Tricare, according to Wednesday’s release.
    • “The DOJ once again said fraud enforcement in Medicare Advantage is of “critical importance.” Concerns about MA fraud have grown in recent years as the program has increased in popularity.”

From the public health and medical research front,

  • The Center for Disease Control and Prevention announced today,
    • “Seasonal influenza activity remains elevated across the country. COVID-19 activity has increased in most areas of the country. RSV activity has peaked in many areas of the country.
    • “COVID-19
      • “COVID-19 activity has increased in most areas of the country, with high COVID-19 wastewater levels and elevated emergency department visits and laboratory percent positivity. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
      • “Seasonal influenza activity, including outpatient and emergency department visits, hospitalizations, and deaths, remains elevated across the country. Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
    • “RSV
      • “RSV activity has peaked in many areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. COVID-19 vaccine coverage in older adults has increased compared with the 2023-2024 season. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • The Wall Street Journal reports,
    • Moderna secured a $590 million package from the U.S. Health and Human Services Department to accelerate the development of its bird influenza vaccine as concerns grow about a bird flu pandemic in humans.
    • “The financial package will fund the expansion of clinical studies for up to five additional subtypes of bird influenza and provide additional support for late-stage development and licensure of prepandemic mRNA-based vaccines, the biotechnology company said Friday.
    • “Highly pathogenic avian influenza has been rampant in poultry farms in the U.S., and there have been several recent human cases in dairy and poultry workers, according to the Centers for Disease Control and Prevention.
    • “The current public-health risk is low, but the CDC is watching the situation carefully and working with states to monitor people with animal exposure.
    • “The financial support from the federal government comes ahead of President-elect Donald Trump’s inauguration on Monday, and while Moderna is preparing to advance its mRNA-1018 investigational pandemic influenza vaccine into a Phase 3 trial.
    • “The company plans to present the data at a coming medical meeting.”
  • The Washington Post discusses, “What to know about genetic testing for cancer, and when to request it. Genetic testing is recommended for those with personal and family histories of several types of cancer — including pancreatic and breast cancer.”
  • Cardiovascular Business lets us know,
    • “A “vascular fingerprint” located at the back of the eye can help predict a person’s stroke risk, according to new data published in Heart. Researchers noted that this new approach could be just as effective as more traditional risk factors. 
    • “The study focused on an advanced artificial intelligence (AI) algorithm trained to evaluate more than 100 different details about a patient’s retinal blood vessels using high-quality photos of the inside of their eye. The AI model assessed data from more than 45,000 participants with an average age of 55 years old. More than 700 of those participants experienced a stroke over an average follow-up period of 12.5 years. All data came from the large-scale UK Biobank study, which tracks lifestyle and health information about hundreds of thousands of participants.
    • “Overall, 29 different parameters were linked to directly influencing a participant’s stroke risk. Changes in some of those parameters increased the risk of stroke by up to 19%.
    • “The performance of this vascular fingerprint, combined with the participant’s age and sex, was found to be comparable to more traditional risk factors.
    • “Given that age and sex are readily available, and retinal parameters can be obtained through routine fundus photography, this model presents a practical and easily implementable approach for incident stroke risk assessment, particularly for primary healthcare and low-resource settings,” wrote Mayinuer Yusufu, a researcher with the department of surgery at The University of Melbourne in Australia, and colleagues.
    • “The group added that retinal analysis sets the stage for “easier, more accessible stroke risk screening, especially in primary care settings.”
  • Per STAT News,
    • “A high dose of Novo Nordisk’s obesity drug Wegovy led patients to lose substantial weight in a clinical trial, but still less than what’s been seen with competitor Eli Lilly’s Zepbound.
    • “In a 72-week study, a 7.2-milligram dose of Wegovy led patients with obesity to lose 18.7% of their weight, when looking at all participants regardless of how well they adhered to treatment. That compared with 15.6% weight loss among people taking the currently approved 2.4-mg dose, and 3.9% among people taking placebo, Novo said Friday.
    • Zepbound led to 20.9% weight loss over 72 weeks in its pivotal trial.

From the U.S. healthcare business front,

  • Beckers Payer Issues tells us,
    • “The medical cost challenges that have challenged insurers in 2024 will not be going away in 2025, UnitedHealth Group executives said
    • “The nation’s largest insurer reported its fourth-quarter and full-year 2024 earnings Jan. 16. UnitedHealth Group’s medical loss ratio was 85.5% in 2024, up from 83.2% in 2023. * * *
    • “The company said it expects its medical loss ratio to increase to around 86.5%. UnitedHealth also expects to see similar medical costs in 2025 to 2024, Mr. Rex told investors. The Inflation Reduction Act and continued risk adjustment changes in Medicare Advantage will also contribute to the rising expenses, he said. 
    • “The company has cut its operating costs as medical costs rise, Mr. Rex said.
    • “Some of these advances are the result of the very early-stage impacts we are beginning to realize from AI-driven initiatives to help our customer service representatives respond to consumers’ needs more effectively and quickly,” he said. “We see continuing opportunities, both in the near term, with operating costs for ’25 improving further, and well beyond, given the rapidly expanding scope and impact of these initiatives.” 
  • MedTech Dive provides its own “JPM25 recap: Robotics, PFA and OTC glucose sensors in the spotlight. CEOs from Medtronic, Intuitive Surgical, Boston Scientific and Dexcom were on hand this week in San Francisco to discuss the year ahead at the J.P. Morgan Healthcare Conference.”
  • Beckers Hospital Review calls attention to “10 healthcare billing fraud cases that Becker’s has reported since Dec. 27.”